ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
FDA 510(k) clearance K992723 · decided 1999-10-18
Clearance details
- K-number
- K992723
- Device name
- ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
- Applicant
- Transfusion Technologies Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-13
- Decision date
- 1999-10-18
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Natick, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-EN recall (Z-2420-2011) | Haemonetics Corporation | 2011-06-07 |