CARDIO-PAK BASIC PUMP PACK
FDA 510(k) clearance K923231 · decided 1993-07-09
Clearance details
- K-number
- K923231
- Device name
- CARDIO-PAK BASIC PUMP PACK
- Applicant
- Cardio-Med-Associates, Inc.
- Decision
- Unknown
- Date received
- 1992-07-01
- Decision date
- 1993-07-09
- Days to decision
- 373 days
- Clearance type
- Traditional
- Product code
- DWE
- Device class
- 2
- Regulation number
- 870.4390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Billings, MT, US
- Third-party review
- No
- Expedited review
- No
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| JOSTRA HLM TUBING SET (K053025) | Maquet Cardiopulmonary, AG | 2005-11-10 |
| PUMP TUBING WITH X-COATING (K022857) | Terumo Cardiovascular Systems Corporation | 2002-09-19 |
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| 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 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Custom surgical packs for a variety of surgical applications. Each pack is custom assemble recall (Z-0753-03) | Windstone Medical, Inc. | 2003-04-22 |