# Flowcardia, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 11 (2005–2010): 11 510(k) clearances
- Product codes: DQY (5), PDU (3), DQX (2), DXT (1)
- Predicates its devices cite: 16 (8 its own); citations of its devices by later devices: 17 (8 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Jomed, Inc.: 2 (https://510kreport.com/company/jomed)
- Guidant Corp.: 2 (https://510kreport.com/company/guidant)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)
- Medtronics Interventional Vascular: 1 (https://510kreport.com/company/medtronics-interventional-vascular)
- Intra Luminal Therapeutics, Inc.: 1 (https://510kreport.com/company/intra-luminal-therapeutics)
- Medrad, Inc.: 1 (https://510kreport.com/company/medrad)

## Firms that cite its devices most
- C.R. Bard, Inc.: 5 (https://510kreport.com/company/cr-bard)
- Revascular Therapeutics, Inc.: 2 (https://510kreport.com/company/revascular-therapeutics)
- Avinger, Inc.: 1 (https://510kreport.com/company/avinger)
- Soundbite Medical Solution, Inc.: 1 (https://510kreport.com/company/soundbite-medical-solution)

## Its most-cited devices
- K072776: The Crosser System (2007), cited by 5
- K062868: The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 (2007), cited by 3
- K051580: VP Sheath (2005), cited by 2
- K092175: The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200 (2010), cited by 2
- K091119: Modification to the Crosser System (2009), cited by 2
- K080849: Microsheath LP and LP-at (2008), cited by 1

## Recent decisions
- K092175: The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200 (Feb 17, 2010)
- K090621: Flowcardia Flowmater Injector, Model Inj 100 (Jun 19, 2009)
- K091254: The Crosser 14 Otw Catheter, Model CRU014 (May 29, 2009)
- K091119: Modification to the Crosser System (May 15, 2009)
- K080849: Microsheath LP and LP-at (Jul 25, 2008)
- K080765: Crosser LP System (Jun 20, 2008)
- K073289: Microsheath XL Catheters (Jan 11, 2008)
- K072776: The Crosser System (Dec 7, 2007)

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