IN.PACT™ AV
GUDID 00763000232986
DCB IAV04004013P 04.00 L040 UL1300 US
MEDTRONIC, INC.
Peripheral angioplasty balloon catheter, drug-coated| Primary Device ID | 00763000232986 |
| NIH Device Record Key | 5b915abe-2bbe-4a26-b0ce-b64ef95067b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IN.PACT™ AV |
| Version Model Number | IAV04004013P |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 40 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000232986 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P190008
FDA Product Code
| PRC | Drug-coated peripheral transluminal angioplasty catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-16 |
| Device Publish Date | 2019-12-06 |
On-Brand Devices [IN.PACT™ AV]
| 00763000233228 | DCB IAV10004013P 10.00 L040 UL1300 US |
| 00763000233211 | DCB IAV09008013P 09.00 L080 UL1300 US |
| 00763000233204 | DCB IAV09006013P 09.00 L060 UL1300 US |
| 00763000233198 | DCB IAV09004013P 09.00 L040 UL1300 US |
| 00763000233181 | DCB IAV08008013P 08.00 L080 UL1300 US |
| 00763000233174 | DCB IAV08006013P 08.00 L060 UL1300 US |
| 00763000233167 | DCB IAV08004013P 08.00 L040 UL1300 US |
| 00763000233150 | DCB IAV07008013P 07.00 L080 UL1300 US |
| 00763000233143 | DCB IAV07006013P 07.00 L060 UL1300 US |
| 00763000233136 | DCB IAV07004013P 07.00 L040 UL1300 US |
| 00763000233112 | DCB IAV06012013P 06.00 L120 UL1300 US |
| 00763000233105 | DCB IAV06008013P 06.00 L080 UL1300 US |
| 00763000233099 | DCB IAV06006013P 06.00 L060 UL1300 US |
| 00763000233082 | DCB IAV06004013P 06.00 L040 UL1300 US |
| 00763000233068 | DCB IAV05012013P 05.00 L120 UL1300 US |
| 00763000233051 | DCB IAV05008013P 05.00 L080 UL1300 US |
| 00763000233044 | DCB IAV05006013P 05.00 L060 UL1300 US |
| 00763000233037 | DCB IAV05004013P 05.00 L040 UL1300 US |
| 00763000233013 | DCB IAV04012013P 04.00 L120 UL1300 US |
| 00763000233006 | DCB IAV04008013P 04.00 L080 UL1300 US |
| 00763000232993 | DCB IAV04006013P 04.00 L060 UL1300 US |
| 00763000232986 | DCB IAV04004013P 04.00 L040 UL1300 US |
| 00763000232962 | DCB IAV10004004P 10.00 L040 UL0400 US |
| 00763000232955 | DCB IAV09008004P 09.00 L080 UL0400 US |
| 00763000232948 | DCB IAV09006004P 09.00 L060 UL0400 US |
| 00763000232931 | DCB IAV09004004P 09.00 L040 UL0400 US |
| 00763000232924 | DCB IAV08008004P 08.00 L080 UL0400 US |
| 00763000232917 | DCB IAV08006004P 08.00 L060 UL0400 US |
| 00763000232900 | DCB IAV08004004P 08.00 L040 UL0400 US |
| 00763000232894 | DCB IAV07008004P 07.00 L080 UL0400 US |
| 00763000232887 | DCB IAV07006004P 07.00 L060 UL0400 US |
| 00763000232870 | DCB IAV07004004P 07.00 L040 UL0400 US |
| 00763000232856 | DCB IAV06012004P 06.00 L120 UL0400 US |
| 00763000232849 | DCB IAV06008004P 06.00 L080 UL0400 US |
| 00763000232832 | DCB IAV06006004P 06.00 L060 UL0400 US |
| 00763000232825 | DCB IAV06004004P 06.00 L040 UL0400 US |
| 00763000232801 | DCB IAV05012004P 05.00 L120 UL0400 US |
| 00763000232795 | DCB IAV05008004P 05.00 L080 UL0400 US |
| 00763000232788 | DCB IAV05006004P 05.00 L060 UL0400 US |
| 00763000232771 | DCB IAV05004004P 05.00 L040 UL0400 US |
| 00763000232757 | DCB IAV04012004P 04.00 L120 UL0400 US |
| 00763000232740 | DCB IAV04008004P 04.00 L080 UL0400 US |
| 00763000232733 | DCB IAV04006004P 04.00 L060 UL0400 US |
| 00763000232726 | DCB IAV04004004P 04.00 L040 UL0400 US |
| 00763000232702 | DCB IAV10004008P 10.00 L040 UL0800 US |
| 00763000232696 | DCB IAV09008008P 09.00 L080 UL0800 US |
| 00763000232689 | DCB IAV09006008P 09.00 L060 UL0800 US |
| 00763000232672 | DCB IAV09004008P 09.00 L040 UL0800 US |
| 00763000232665 | DCB IAV08008008P 08.00 L080 UL0800 US |
| 00763000232658 | DCB IAV08006008P 08.00 L060 UL0800 US |
Trademark Results [IN.PACT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IN.PACT 79320694 not registered Live/Pending |
INVATEC Technology Center GmbH 2021-08-10 |
 IN.PACT 79074790 3864435 Dead/Cancelled |
INVATEC Technology Center GmbH 2009-06-19 |
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