HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
FDA 510(k) clearance K053000 · decided 2005-11-21
Clearance details
- K-number
- K053000
- Device name
- HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
- Applicant
- Haemonetics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-25
- Decision date
- 2005-11-21
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Braintree, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US M recall (Z-2956-2011) | Haemonetics Corporation | 2011-08-05 |
| Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US recall (Z-1391-2011) | Haemonetics Corporation | 2011-02-22 |
| Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintre recall (Z-0358-2008) | Haemonetics Corporation | 2007-12-08 |