VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
FDA 510(k) clearance K062832 · decided 2006-10-20
Clearance details
- K-number
- K062832
- Device name
- VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-21
- Decision date
- 2006-10-20
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140. recall (Z-0183-2009) | Bard Peripheral Vascular Inc | 2008-10-22 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |