THORAX-KLEX CHEST DRAINAGE UNIT
FDA 510(k) clearance K830671 · decided 1983-03-29
Clearance details
- K-number
- K830671
- Device name
- THORAX-KLEX CHEST DRAINAGE UNIT
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-04
- Decision date
- 1983-03-29
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- KDQ
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Warrendale, PA, 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 |
|---|---|---|
| EXPRESS CHEST DRAIN (K081718) | Atrium Medical Corp. | 2008-07-25 |
| MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (K062302) | Millicore AB | 2006-10-06 |
| OCEAN CHEST DRAIN (K043582) | Atrium Medical Corp. | 2005-01-21 |
| ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (K984496) | Atrium Medical Corp. | 1999-05-05 |
| PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR (K962856) | Deknatel, Inc. | 1996-08-28 |
| ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (K961287) | Rocket Medical Plc | 1996-07-26 |
| MUCUS SPECIMEN TRAP (K962168) | Sage Products, Inc. | 1996-07-22 |
| ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (K950677) | Atrium Medical Corp. | 1995-04-13 |
| PM9000 VAC TRAP (K941818) | Precision Medical, Inc. | 1994-12-12 |
| THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (K932327) | Davol, Inc. | 1993-07-13 |
| ATRIUM 2000 CHEST DRAIN (K912704) | Atrium Medical Corp. | 1991-08-26 |
| PLEUR-EVAC CHEST DRAINAGE SYSTEMS (K905768) | Deknatel, Inc. | 1991-02-11 |
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 |