CENTRIFUGAL PUMP
FDA 510(k) clearance K011838 · decided 2002-02-05
Clearance details
- K-number
- K011838
- Device name
- CENTRIFUGAL PUMP
- Applicant
- Stockert Instrumente GmbH
- Decision
- Substantially Equivalent
- Date received
- 2001-06-12
- Decision date
- 2002-02-05
- Days to decision
- 238 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S0912 recall (Z-0166-2013) | Sorin Group USA, Inc. | 2012-10-29 |
| SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S0913 recall (Z-0167-2013) | Sorin Group USA, Inc. | 2012-10-29 |