BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
FDA 510(k) clearance K033814 · decided 2004-03-01
Clearance details
- K-number
- K033814
- Device name
- BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-09
- Decision date
- 2004-03-01
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- FTL
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cranston, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch i recall (Z-2239-2011) | Davol, Inc., Sub. C. R. Bard, Inc. | 2011-05-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web (P800002/S035) | C.R. Bard, Inc. | 2026-07-15 |
| 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 |