FLAIR ENDOVASCULAR STENT GRAFT
FDA premarket approval P060002 · decided 2007-07-23
Approval details
- PMA number
- P060002
- Trade name
- FLAIR ENDOVASCULAR STENT GRAFT
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular
- Date received
- 2006-01-17
- Decision date
- 2007-07-23
- Days to decision
- 552 days
- Decision code
- APWD
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR THE FLAIR ENDOVASCULAR STENT GRAFT. THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF STENOSES AT THE VENOUS ANASTOMOSIS OF EPTFE OR OTHER SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFTS.
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510(k) clearances by this applicant
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| BD Trek Powered Bone Biopsy System (K213896) | Bard Peripheral Vascular | 2022-03-30 |
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| MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F (K062887) | Bard Peripheral Vascular | 2006-10-26 |
| FLUENCY TRACHEOBRONCHIAL STENT GRAFT (K031041) | Bard Peripheral Vascular | 2003-06-19 |