# Cobe Cardiovascular, Inc.

- Location (FDA's records): Arvada, CO
- FDA decisions: 43 (1992–2005): 43 510(k) clearances
- Product codes: DTN (9), DTZ (8), CAC (7), DTR (3), DTM (3), DTP (2), KFM (2), DWF (2), DQO (1), DWE (1), DRT (1), JQC (1)
- Predicates its devices cite: 20 (11 its own); citations of its devices by later devices: 36 (11 its own)
- Recalls linked to its devices: 32 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sorin Biomedical, Inc.: 2 (https://510kreport.com/company/sorin-biomedical)
- Dideco S.P.A.: 2 (https://510kreport.com/company/dideco)
- Bio Medicus, Inc.: 1 (https://510kreport.com/company/bio-medicus)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- American Omni Medical, Inc.: 1 (https://510kreport.com/company/american-omni-medical)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Firms that cite its devices most
- Sorin Group Italia S.R.L.: 8 (https://510kreport.com/company/sorin-group-italia)
- Dideco S.P.A.: 7 (https://510kreport.com/company/dideco)
- Rand S.R.L.: 2 (https://510kreport.com/company/rand)
- Qura S.R.L: 2 (https://510kreport.com/company/qura)
- LivaNova USA, Inc.: 2 (https://510kreport.com/company/livanova-usa)
- Maquet Cardiopulmonary, AG: 2 (https://510kreport.com/company/maquet-cardiopulmonary)
- Century Hlm, LLC: 1 (https://510kreport.com/company/century-hlm)
- International Biophysics Corp.: 1 (https://510kreport.com/company/international-biophysics)

## Its most-cited devices
- K002493: Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation) Newborn/Infant Arterial Filter (2000), cited by 5
- K011835: Cobe Revolution (2002), cited by 4
- K960974: Cobe Century Perfusion Pump (1997), cited by 3
- K030462: Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700 (2003), cited by 3
- K933625: Brat 2 Autologus Blood Salvage System (1993), cited by 2
- K040184: Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter (2004), cited by 2

## Recent decisions
- K050111: Smarxt BMR 1900 Closed Venous Reservoir Bag (Mar 8, 2005)
- K042473: Cobe Angel Whole Blood Separation System (Nov 19, 2004)
- K040184: Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter (Feb 26, 2004)
- K033641: Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800 (Dec 11, 2003)
- K030462: Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700 (Mar 6, 2003)
- K021830: Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System (Jul 2, 2002)
- K011835: Cobe Revolution (Feb 12, 2002)
- K013480: Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane Oxygenator (Nov 16, 2001)

Source page: https://510kreport.com/company/cobe-cardiovascular