510(k) K032040 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, Jul 9, 2003 |
| Received | Jul 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032040
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2012 | Sorin Group USA, Inc. SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung bypass, Sterile EO, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy.
Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.