DYNAFLO BYPASS GRAFT
FDA 510(k) clearance K050049 · decided 2005-01-31
Clearance details
- K-number
- K050049
- Device name
- DYNAFLO BYPASS GRAFT
- Applicant
- Bard Peripheral Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-10
- Decision date
- 2005-01-31
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783) | Peca Labs, Inc. | 2024-01-17 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| HeRO Graft (K213845) | Merit Medical Systems, Inc. | 2022-08-15 |
| exGraft, exGraft Carbon (K221628) | Peca Labs | 2022-08-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LifeStent® Vascular Stent Systems (P070014/S066) | Bard Peripheral Vascular, Inc. | 2025-12-16 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S014) | Bard Peripheral Vascular, Inc. | 2025-09-29 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S013) | Bard Peripheral Vascular, Inc. | 2025-08-13 |
| Venovo Venous Stent System (P180037/S014) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S013) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| LifeStent Vascular Stent System (P070014/S065) | Bard Peripheral Vascular, Inc. | 2023-07-27 |
| Fluency Endovascular Stent Graft (P130029/S012) | Bard Peripheral Vascular, Inc. | 2023-02-17 |
| LifeStent 5F Vascular Stent Systems (P070014/S064) | Bard Peripheral Vascular, Inc. | 2023-02-02 |