Company ยท US
Sorin Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1999. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 5, 1999 | K990103 | MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE Sorin Biomedical, Inc. | DTZ |
| Feb 20, 1998 | K963759 | DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS Sorin Biomedical, Inc. | CAC |
| Feb 20, 1998 | K963758 | CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE Sorin Biomedical, Inc. | CAC |
| Sep 3, 1997 | K964908 | VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER Sorin Biomedical, Inc. | DTN |
| Aug 21, 1997 | K964907 | VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT Sorin Biomedical, Inc. | DTN |
| Aug 12, 1996 | K961869 | DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 Sorin Biomedical, Inc. | DTM |
| Aug 21, 1995 | K952270 | DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN Sorin Biomedical, Inc. | DTM |
| Jun 27, 1995 | K945198 | DIDECO PEDIATRIC ARTERIAL FILTERS Sorin Biomedical, Inc. | DTM |
| May 19, 1995 | K945065 | DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 Sorin Biomedical, Inc. | DTN |
| May 10, 1995 | K941215 | VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR Sorin Biomedical, Inc. | DTN |
| Jan 27, 1995 | K942582 | SORIN BLOOD CARDIOPLEGIA CONSOLE Sorin Biomedical, Inc. | DTQ |
| Apr 15, 1994 | K934847 | NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS Sorin Biomedical, Inc. | DTN |
| Apr 15, 1994 | K934763 | SORIN BLOOD CARDIOPLEGIA SYSTEM Sorin Biomedical, Inc. | DTN |
| Mar 23, 1994 | K936183 | SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS Sorin Biomedical, Inc. | DTN |
| Nov 2, 1993 | K933481 | SORIN MONOLYTH VENOUS RESERVOIR Sorin Biomedical, Inc. | DTN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||