Sorin Biomedical, Inc.
Irvine, CA, US
Sorin Biomedical, Inc. appears in FDA device records in Irvine, CA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Sorin Biomedical, Inc. between 1993 and 1999. The busiest year on record is 1995, with 5. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 5 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990103 | MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE | DTZ | Substantially Equivalent | |
| K963759 | DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS | CAC | Substantially Equivalent | |
| K963758 | CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE | CAC | Substantially Equivalent | |
| K964908 | VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER | DTN | Substantially Equivalent | |
| K964907 | VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT | DTN | Substantially Equivalent | |
| K961869 | DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 | DTM | Substantially Equivalent | |
| K952270 | DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN | DTM | Substantially Equivalent | |
| K945198 | DIDECO PEDIATRIC ARTERIAL FILTERS | DTM | Substantially Equivalent | |
| K945065 | DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 | DTN | Substantially Equivalent | |
| K941215 | VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR | DTN | Substantially Equivalent | |
| K942582 | SORIN BLOOD CARDIOPLEGIA CONSOLE | DTQ | Substantially Equivalent | |
| K934847 | NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS | DTN | Substantially Equivalent | |
| K934763 | SORIN BLOOD CARDIOPLEGIA SYSTEM | DTN | Substantially Equivalent | |
| K936183 | SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS | DTN | Substantially Equivalent | |
| K933481 | SORIN MONOLYTH VENOUS RESERVOIR | DTN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain