Fortrex™
GUDID 00763000634360
PTA A35HPV05040040 FORTREX V04
MEDTRONIC, INC.
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00763000634360 |
| NIH Device Record Key | 076fc32c-befd-436d-8bb3-4964f9efefa9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortrex™ |
| Version Model Number | A35HPV05040040 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
| Outer Diameter | 5 Millimeter |
| Catheter Gauge | 6 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Rotate inventory so that the device is used before the Use-by date on the package label. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000634360 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142654
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
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 | 2024-02-23 |
| Device Publish Date | 2024-02-15 |
On-Brand Devices [Fortrex™]
| 00763000634957 | PTA A35HPV12080135 FORTREX V04 |
| 00763000634940 | PTA A35HPV12080080 FORTREX V04 |
| 00763000634933 | PTA A35HPV12080040 FORTREX V04 |
| 00763000634926 | PTA A35HPV12040135 FORTREX V04 |
| 00763000634919 | PTA A35HPV12040080 FORTREX V04 |
| 00763000634902 | PTA A35HPV12040040 FORTREX V04 |
| 00763000634896 | PTA A35HPV10080135 FORTREX V04 |
| 00763000634889 | PTA A35HPV10080080 FORTREX V04 |
| 00763000634872 | PTA A35HPV10080040 FORTREX V04 |
| 00763000634865 | PTA A35HPV10040135 FORTREX V04 |
| 00763000634858 | PTA A35HPV10040080 FORTREX V04 |
| 00763000634841 | PTA A35HPV10040040 FORTREX V04 |
| 00763000634834 | PTA A35HPV09080135 FORTREX V04 |
| 00763000634827 | PTA A35HPV09080080 FORTREX V04 |
| 00763000634810 | PTA A35HPV09080040 FORTREX V04 |
| 00763000634803 | PTA A35HPV09040135 FORTREX V04 |
| 00763000634797 | PTA A35HPV09040080 FORTREX V04 |
| 00763000634780 | PTA A35HPV09040040 FORTREX V04 |
| 00763000634773 | PTA A35HPV08100135 FORTREX V04 |
| 00763000634766 | PTA A35HPV08100080 FORTREX V04 |
| 00763000634759 | PTA A35HPV08100040 FORTREX V04 |
| 00763000634742 | PTA A35HPV08080135 FORTREX V04 |
| 00763000634735 | PTA A35HPV08080080 FORTREX V04 |
| 00763000634728 | PTA A35HPV08080040 FORTREX V04 |
| 00763000634711 | PTA A35HPV08040135 FORTREX V04 |
| 00763000634704 | PTA A35HPV08040080 FORTREX V04 |
| 00763000634698 | PTA A35HPV08040040 FORTREX V04 |
| 00763000634681 | PTA A35HPV07100135 FORTREX V04 |
| 00763000634674 | PTA A35HPV07100080 FORTREX V04 |
| 00763000634667 | PTA A35HPV07100040 FORTREX V04 |
| 00763000634650 | PTA A35HPV07080135 FORTREX V04 |
| 00763000634643 | PTA A35HPV07080080 FORTREX V04 |
| 00763000634636 | PTA A35HPV07080040 FORTREX V04 |
| 00763000634629 | PTA A35HPV07040135 FORTREX V04 |
| 00763000634612 | PTA A35HPV07040080 FORTREX V04 |
| 00763000634605 | PTA A35HPV07040040 FORTREX V04 |
| 00763000634599 | PTA A35HPV07020135 FORTREX V04 |
| 00763000634582 | PTA A35HPV07020080 FORTREX V04 |
| 00763000634575 | PTA A35HPV07020040 FORTREX V04 |
| 00763000634568 | PTA A35HPV06100135 FORTREX V04 |
| 00763000634551 | PTA A35HPV06100080 FORTREX V04 |
| 00763000634544 | PTA A35HPV06100040 FORTREX V04 |
| 00763000634537 | PTA A35HPV06080135 FORTREX V04 |
| 00763000634520 | PTA A35HPV06080080 FORTREX V04 |
| 00763000634513 | PTA A35HPV06080040 FORTREX V04 |
| 00763000634506 | PTA A35HPV06040135 FORTREX V04 |
| 00763000634490 | PTA A35HPV06040080 FORTREX V04 |
| 00763000634483 | PTA A35HPV06040040 FORTREX V04 |
| 00763000634476 | PTA A35HPV06020135 FORTREX V04 |
| 00763000634469 | PTA A35HPV06020080 FORTREX V04 |
Trademark Results [Fortrex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTREX 98862822 not registered Live/Pending |
Packers Sanitation Services, Inc., Ltd. 2024-11-20 |
 FORTREX 97438582 not registered Live/Pending |
Kent Nutrition Group, Inc. 2022-06-01 |
 FORTREX 97010416 not registered Live/Pending |
Cooper-Standard Automotive Inc. 2021-09-03 |
 FORTREX 88170628 not registered Live/Pending |
Schweitzer-Mauduit International, Inc. 2018-10-26 |
 FORTREX 88144654 not registered Live/Pending |
Cooper-Standard Automotive Inc. 2018-10-05 |
 FORTREX 88093815 not registered Live/Pending |
Cooper-Standard Automotive Inc. 2018-08-27 |
 FORTREX 86983024 5307518 Live/Registered |
Cooper-Standard Automotive Inc. 2014-07-21 |
 FORTREX 86387647 4928336 Live/Registered |
Covidien LP 2014-09-08 |
 FORTREX 86343246 not registered Dead/Abandoned |
Cooper-Standard Automotive Inc. 2014-07-21 |
 FORTREX 85957797 4432639 Live/Registered |
DRIFIRE, LLC 2013-06-12 |
 FORTREX 77347860 3544770 Live/Registered |
Johnson Outdoors Inc. 2007-12-10 |
 FORTREX 76089077 not registered Dead/Abandoned |
Perez, Alain 2000-07-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.