510(k) K991737 ยท DTZ Oxygenator, Cardiopulmonary Bypass
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, Feb 17, 2000 |
| Received | May 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991737
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2008 | Sorin Group USA, Inc. Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmon Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.