# Sorin Biomedical, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 15 (1993–1999): 15 510(k) clearances
- Product codes: DTN (8), DTM (3), CAC (2), DTQ (1), DTZ (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 20 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shiley, Inc.: 2 (https://510kreport.com/company/shiley)
- Sorin Biomedica, Fiat, USA, Inc.: 1 (https://510kreport.com/company/sorin-biomedica-fiat-usa)

## Firms that cite its devices most
- Dideco S.P.A.: 9 (https://510kreport.com/company/dideco)
- Sorin Group Italia S.R.L.: 4 (https://510kreport.com/company/sorin-group-italia)
- Cobe Cardiovascular, Inc.: 2 (https://510kreport.com/company/cobe-cardiovascular)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)
- Medtronic Bio-Medicus, Inc.: 1 (https://510kreport.com/company/medtronic-bio-medicus)
- Gish Biomedical, Inc.: 1 (https://510kreport.com/company/gish-biomedical)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Its most-cited devices
- K934847: Ngbcd & Ngbcdp Cardioplegia Delivery Systems (1994), cited by 4
- K952270: Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron Screen (1995), cited by 3
- K933481: Sorin Monolyth Venous Reservoir (1993), cited by 2
- K961869: Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40 (1996), cited by 2
- K934763: Sorin Blood Cardioplegia System (1994), cited by 2
- K963759: Dideco Compact-a and Compact-M Autotransfusion Systems (1998), cited by 2

## Recent decisions
- K990103: Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir , CVR 600 and 1200 Softshe (Nov 5, 1999)
- K963758: Code 150 Blood Component Collection Set and with Direct Draw Line (Feb 20, 1998)
- K963759: Dideco Compact-a and Compact-M Autotransfusion Systems (Feb 20, 1998)
- K964908: VRF40 Venous Reservoir with Integral Cardiotomy Filter (Sep 3, 1997)
- K964907: Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy Reservoir with Filt (Aug 21, 1997)
- K961869: Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40 (Aug 12, 1996)
- K952270: Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron Screen (Aug 21, 1995)
- K945198: Dideco Pediatric Arterial Filters (Jun 27, 1995)

Source page: https://510kreport.com/company/sorin-biomedical