SORIN CENTRIFUGAL PUMP 5 (CP5)
FDA 510(k) clearance K112225 · decided 2011-09-20
Clearance details
- K-number
- K112225
- Device name
- SORIN CENTRIFUGAL PUMP 5 (CP5)
- Applicant
- Sorin Group Deutschland GmbH
- Decision
- Substantially Equivalent
- Date received
- 2011-08-03
- Decision date
- 2011-09-20
- Days to decision
- 48 days
- Clearance type
- Special
- Product code
- DWA
- Device class
- 2
- Regulation number
- 870.4380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to recall (Z-0857-2014) | Sorin Group Deutschland GmbH | 2014-01-28 |
| Pump control panel. The S5 Perfusion System is used to perform, control and monitor extrac recall (Z-1329-2012) | Sorin Group Deutschland GmbH | 2012-03-29 |