AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
FDA 510(k) clearance K982650 · decided 1998-12-16
Clearance details
- K-number
- K982650
- Device name
- AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
- Applicant
- Dideco S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-30
- Decision date
- 1998-12-16
- Days to decision
- 139 days
- Clearance type
- Abbreviated
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, recall (Z-1488-06) | Cobe Cardiovascular, Inc | 2006-09-09 |
| Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C recall (Z-1490-06) | Cobe Cardiovascular, Inc | 2006-09-09 |