GENTLE HEADER
FDA 510(k) clearance K902845 · decided 1990-12-03
Clearance details
- K-number
- K902845
- Device name
- GENTLE HEADER
- Applicant
- Enhanced Perfusion Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-28
- Decision date
- 1990-12-03
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- DWE
- Device class
- 2
- Regulation number
- 870.4390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Grass Lake, MI, 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 |
|---|---|---|
| SMARxT Tubing and Connectors (K233702) | LivaNova USA, Inc. | 2024-08-08 |
| Terumo Pump Tubing (K150542) | Terumo Cardiovascular Systems Corporation | 2015-05-01 |
| AngioVac Circuit (K142607) | Angiodynamics | 2014-12-11 |
| VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT (K092486) | Vortex Medical, Inc. | 2009-08-28 |
| HLM TUBING SET WITH BIOLINE COATING (K080592) | Maquet Cardiopulmonary, AG | 2008-09-11 |
| JOSTRA HLM TUBING SET (K053025) | Maquet Cardiopulmonary, AG | 2005-11-10 |
| PUMP TUBING WITH X-COATING (K022857) | Terumo Cardiovascular Systems Corporation | 2002-09-19 |
| PUMP TUBING (K013578) | Terumo Cardiovascular Systems Corp. | 2002-01-22 |
| CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING (K993189) | Terumo Corp. | 2000-03-01 |
| CHEST DRAINAGE TUBING (K993062) | Olson Medical Sales, Inc. | 1999-12-10 |
| COBE SMARXT TUBING AND CONNECTORS (K981613) | Cobe Cardiovascular, Inc. | 1998-10-26 |
| CARDIO-PAK BASIC PUMP PACK (K923231) | Cardio-Med-Associates, Inc. | 1993-07-09 |
Recalls involving this device
No recalls on record reference this clearance.