BARD MALECOT AND PEZZER DRAINS
FDA 510(k) clearance K070879 · decided 2007-04-24
Clearance details
- K-number
- K070879
- Device name
- BARD MALECOT AND PEZZER DRAINS
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-30
- Decision date
- 2007-04-24
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- FEW
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Covington, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (K140085) | Cook Incorporated | 2014-11-18 |
| MANAN MALECOT BASKET DRAINAGE CATHETER (K981258) | Medical Device Technologies, Inc. | 1998-04-22 |
| MANAN MALECOT BASKET DRAINAGE CATHETER (K954147) | Manan Medical Products, Inc. | 1996-03-26 |
| SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (K954116) | Technical Products, Inc. | 1995-11-06 |
| OLYMPIC SMART SCALE CARE CENTER (K920423) | Olympic Medical Corp. | 1992-06-11 |
Recalls involving this device
No recalls on record reference this clearance.
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 |