COBE REVOLUTION
FDA 510(k) clearance K011835 · decided 2002-02-12
Clearance details
- K-number
- K011835
- Device name
- COBE REVOLUTION
- Applicant
- Cobe Cardiovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-12
- Decision date
- 2002-02-12
- Days to decision
- 245 days
- Clearance type
- Abbreviated
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arvada, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN G recall (Z-0192-2010) | Sorin Group USA, Inc. | 2009-11-13 |