OCEAN CHEST DRAIN
FDA 510(k) clearance K043582 · decided 2005-01-21
Clearance details
- K-number
- K043582
- Device name
- OCEAN CHEST DRAIN
- Applicant
- Atrium Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-28
- Decision date
- 2005-01-21
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- KDQ
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hudson, NH, 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 |
| 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 |
| ATRIUM 2000, CHEST DRAIN (K897125) | Atrium Medical Corp. | 1990-03-30 |
Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| iCast Covered Stent System (P120003/S009) | Atrium Medical Corp. | 2025-12-22 |
| iCast Covered Stent System (P120003/S011) | Atrium Medical Corp. | 2025-09-12 |
| iCast Covered Stent System (P120003/S010) | Atrium Medical Corp. | 2025-08-20 |
| iCast Covered Stent System (P120003/S006) | Atrium Medical Corp. | 2025-07-07 |
| iCast Covered Stent System (P120003/S008) | Atrium Medical Corp. | 2025-05-01 |
| iCast Covered Stent System (P120003/S005) | Atrium Medical Corp. | 2024-08-07 |
| iCast Covered Stent System (P120003/S004) | Atrium Medical Corp. | 2024-07-24 |
| iCast Covered Stent System (P120003/S003) | Atrium Medical Corp. | 2023-10-18 |