# Cardiacassist, Inc.

- Location (FDA's records): Pittsburgh, PA
- FDA decisions: 21 (2000–2024): 21 510(k) clearances
- Product codes: DWF (9), KFM (4), QNR (3), DRE (1), DQR (1), DWA (1), PZS (1), DTZ (1)
- 510(k) review time since 2016: median 105 days, against 32 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 33 (17 its own); citations of its devices by later devices: 25 (17 its own)
- Recalls linked to its devices: 15 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Bio-Medicus, Inc.: 5 (https://510kreport.com/company/medtronic-bio-medicus)
- Avalon Laboratories, LLC: 3 (https://510kreport.com/company/avalon-laboratories)
- Bio Medicus, Inc.: 2 (https://510kreport.com/company/bio-medicus)
- Levitronix, LLC: 2 (https://510kreport.com/company/levitronix)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Electro-Catheter Corp.: 1 (https://510kreport.com/company/electro-catheter)
- Mc3 Incorporated: 1 (https://510kreport.com/company/mc3)
- Novalung GmbH: 1 (https://510kreport.com/company/novalung)

## Firms that cite its devices most
- Abiomed, Inc.: 2 (https://510kreport.com/company/abiomed)
- Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.): 2 (https://510kreport.com/company/michigan-critical-care-consultants-dba-mc3)
- Orqis Medical Corporation: 1 (https://510kreport.com/company/orqis-medical)
- Sorin Group Italia S.R.L.: 1 (https://510kreport.com/company/sorin-group-italia)
- Qura S.R.L: 1 (https://510kreport.com/company/qura)
- Maquet Cardiopulmonary, AG: 1 (https://510kreport.com/company/maquet-cardiopulmonary)

## Its most-cited devices
- K991783: AB-180 XC System, Model AB-180XC (2000), cited by 3
- K140999: Tandemheart Veno-Venous Cannula (2014), cited by 3
- K160257: PROTEK Duo 31 Fr. Veno-Venous Cannula Set (2016), cited by 3
- K133236: Tandemheart Femoral Venous Cannula Set (2014), cited by 2
- K052570: Tandemheart Transseptal Cannula Set-EF, Model 5140-6221 (2006), cited by 2
- K030398: Cardiacassist Transseptal Cannula Set, Model 5132-6221 (2003), cited by 2

## Recent decisions
- K233736: LifeSPARC System (Jan 19, 2024)
- K232480: ProtekDuo Veno-Venous Cannula Sets (Oct 6, 2023)
- K232132: LifeSPARC System (Aug 3, 2023)
- K211830: LifeSPARC System (Nov 15, 2022)
- K202751: TandemHeart Pump and Escort Controller (Mar 26, 2021)
- K183623: LifeSPARC Pump, LifeSPARC Controller (Jul 9, 2019)
- K181150: ProtekDuo Mini Veno-Venous Cannula Set (May 25, 2018)
- K162181: Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (Jan 6, 2017)

Source page: https://510kreport.com/company/cardiacassist