AUTOTRANSFUSION APPARTUS (AUTOLOG)
FDA 510(k) clearance K972894 · decided 1998-04-27
Clearance details
- K-number
- K972894
- Device name
- AUTOTRANSFUSION APPARTUS (AUTOLOG)
- Applicant
- Medtronic Blood Management
- Decision
- Substantially Equivalent
- Date received
- 1997-08-05
- Decision date
- 1998-04-27
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Parker, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufact recall (Z-1939-2010) | Medtronic Cardiovascular Revascularization & Surgical Therap | 2010-06-30 |