Heli-FX™ Thoracic EndoAnchor™ System
GUDID 00763000645168
GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU
MEDTRONIC VASCULAR, INC.
Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable| Primary Device ID | 00763000645168 |
| NIH Device Record Key | dfddfee1-58de-4be6-a252-fe30cbeb3641 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Heli-FX™ Thoracic EndoAnchor™ System |
| Version Model Number | HG-18-90-32 |
| Company DUNS | 080009661 |
| Company Name | MEDTRONIC VASCULAR, 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 | false |
| 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 |
Device Dimensions
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 32 Millimeter |
| Length | 90 Centimeter |
| Outer Diameter | 6 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000645168 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182957
FDA Product Code
| OTD | Endovascular suturing system |
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 | 2022-10-31 |
| Device Publish Date | 2022-10-22 |
On-Brand Devices [Heli-FX™ Thoracic EndoAnchor™ System]
| 00763000645175 | GUIDE HG-18-90-42 TAA ENDOANCH 42 EIFU |
| 00763000645168 | GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU |
| 00763000645151 | GUIDE HG-18-90-22 TAA ENDOANCH 22 EIFU |
| 00763000645144 | ACC HA-18-114 TAA APPL-CASS 10 EIFU US |
Trademark Results [Heli-FX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HELI-FX 85910990 not registered Dead/Abandoned |
Aptus Endosystems, Inc. 2013-04-22 |
 HELI-FX 85426860 4564541 Live/Registered |
MEDTRONIC VASCULAR, INC. 2011-09-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.