DIDECO ELECTA
FDA 510(k) clearance K020647 · decided 2002-09-05
Clearance details
- K-number
- K020647
- Device name
- DIDECO ELECTA
- Applicant
- Dideco S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-28
- Decision date
- 2002-09-05
- Days to decision
- 189 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, Electa Essential , Cobe part numbers WS55E, WS125E, recall (Z-1489-06) | Cobe Cardiovascular, Inc | 2006-09-09 |
| Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE2 recall (Z-1491-06) | Cobe Cardiovascular, Inc | 2006-09-09 |