ECONOMY 400 CWS WITH PVC DRAINS
FDA 510(k) clearance K851084 · decided 1985-06-04
Clearance details
- K-number
- K851084
- Device name
- ECONOMY 400 CWS WITH PVC DRAINS
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-18
- Decision date
- 1985-06-04
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- GCY
- Device class
- 1
- Regulation number
- 878.4680
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Murray Hill, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch C.R. Bard
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REDYROB-CLOSED WOUND DRAINAGE SYSTEM (K972703) | B.Braun Medical, Inc. | 1997-10-01 |
| ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (K971036) | Interpore Intl. | 1997-06-03 |
| CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (K963839) | Cordis Corp. | 1996-12-12 |
| PENROSE DRAIN MODELS 6001 - 6007 (K960099) | Sil-Med Corp. | 1996-03-11 |
| MACRO SUCTION TUBE MODEL NO 10061 (K950754) | Dlp, Inc. | 1995-04-25 |
| PRESSURE IRRIGATING SYSTEM (K936223) | Level 1 Technologies, Inc. | 1994-05-12 |
| AUTOVAC CLOSED WOUND SUCTION SYSTEM (K930615) | Boehringer Laboratories | 1994-02-22 |
| BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM (K933319) | Birtcher Medical Systems, Inc. | 1993-10-27 |
| IMC 5.0MM IRRIGATION/ASPIRATION PROBE (K933305) | Inman Medical Corp. | 1993-10-05 |
| IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (K933306) | Inman Medical Corp. | 1993-10-05 |
| INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (K933170) | Inman Medical Corp. | 1993-09-16 |
| POOLE TIP SUCTION PROBE (K931950) | Mayaguez Medical Center | 1993-08-11 |
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 |