ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
FDA 510(k) clearance K090547 · decided 2009-03-18
Clearance details
- K-number
- K090547
- Device name
- ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-02
- Decision date
- 2009-03-18
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- NEU
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Tr recall (Z-1526-2013) | Bard Peripheral Vascular Inc | 2013-06-10 |
| BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Tr recall (Z-1527-2013) | Bard Peripheral Vascular Inc | 2013-06-10 |
| MICROSHEATH - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0 recall (Z-1528-2013) | Bard Peripheral Vascular Inc | 2013-06-10 |
| USHER Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-P recall (Z-1529-2013) | Bard Peripheral Vascular Inc | 2013-06-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
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| Covera Vascular Covered Stent (P170042/S015) | C.R. Bard, Inc. | 2026-06-10 |
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |