Flair Endovascular Stent Graft
FDA premarket approval P060002/S040 · decided 2018-10-11
Approval details
- PMA number
- P060002
- Supplement
- S040
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Flair Endovascular Stent Graft
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular
- Date received
- 2018-03-16
- Decision date
- 2018-10-11
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for adding a sterilization line at the Bard Regional Sterilization, Madison Facility.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BD Trek Powered Bone Biopsy System (K213896) | Bard Peripheral Vascular | 2022-03-30 |
| EleVation Breast Biopsy System (K211933) | Bard Peripheral Vascular | 2021-07-15 |
| 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 |