510(k) Report

FDA applicant

Flowcardia, Inc.

Sunnyvale, CA11 decisions2005–20101 recall

FDA records 11 decisions for Flowcardia, Inc. (Sunnyvale, CA) from 2005 to 2010: 11 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and PDU (Catheter For Crossing Total Occlusions). Its devices cite 16 predicates, 8 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Flowcardia, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 22008: 32009: 32010: 1
2007high 3 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Flowcardia, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Flowcardia, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQYCatheter, Percutaneous5decisions
  • PDUCatheter For Crossing Total Occlusions3decisions
  • DQXWire, Guide, Catheter2decisions
  • DXTInjector And Syringe, Angiographic1decision

Whose devices does it build on?

Its devices cite 16 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072776The Crosser SystemFlowcardia, Inc. · 20075cite it
  • K062868The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02Flowcardia, Inc. · 20073cite it
  • K051580VP SheathFlowcardia, Inc. · 20052cite it
  • K092175The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200Flowcardia, Inc. · 20102cite it
  • K091119Modification to the Crosser SystemFlowcardia, Inc. · 20092cite it
  • K080849Microsheath LP and LP-atFlowcardia, Inc. · 20081cites it

What has FDA decided for it lately?

  • K092175The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200Flowcardia, Inc. · 2010
  • K090621Flowcardia Flowmater Injector, Model Inj 100Flowcardia, Inc. · 2009
  • K091254The Crosser 14 Otw Catheter, Model CRU014Flowcardia, Inc. · 2009
  • K091119Modification to the Crosser SystemFlowcardia, Inc. · 2009
  • K080849Microsheath LP and LP-atFlowcardia, Inc. · 2008
  • K080765Crosser LP SystemFlowcardia, Inc. · 2008
  • K073289Microsheath XL CathetersFlowcardia, Inc. · 2008
  • K072776The Crosser SystemFlowcardia, Inc. · 20071 recall

All 11 as Flowcardia, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K072776Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia…Jan 9, 2009