510(k) K011835 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
COBE REVOLUTION
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Feb 12, 2002 |
| Received | Jun 12, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K011835
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2009 | Sorin Group USA, Inc. Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.