CARDIO-PAK LAPAROTOMY PACK
FDA 510(k) clearance K923233 · decided 1993-03-20
Clearance details
- K-number
- K923233
- Device name
- CARDIO-PAK LAPAROTOMY PACK
- Applicant
- Cardio-Med-Associates, Inc.
- Decision
- Unknown
- Date received
- 1992-07-01
- Decision date
- 1993-03-20
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- FZH
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Billings, MT, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODEL UCA / SPEC SYSTEM UCA (K875305) | Spec Systems, Inc. | 1988-01-27 |
| ULTRAFLOW (K871901) | Custom Industries, Inc. | 1987-06-01 |
| OPERATING ROOM VENTILATOR (K770084) | Dupaco, Inc. | 1977-02-23 |
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 |