510(k) Report

FDA applicant

Vasonova, Inc.

Sunnyvale, CA8 decisions2008–20135 recalls

FDA records 8 decisions for Vasonova, Inc. (Sunnyvale, CA) from 2008 to 2013: 8 510(k) clearances. Most are in product codes OBJ (Catheter, Ultrasound, Intravascular) and LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 9 predicates, 3 of them its own earlier devices. 5 recalls are 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 Vasonova, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 32009: 22011: 22013: 1
2008high 3 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2017

2015: 32017: 2
2008high 3 (2015) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Vasonova, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OBJCatheter, Ultrasound, Intravascular5decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days3decisions

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 3 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.

  • K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 20115cite it
  • K081625Flowpicc StyletVasonova, Inc. · 20083cite it
  • K081626Flowpicc ConsoleVasonova, Inc. · 20082cite it
  • K103260Vascular Positioning System (VPS System) ConsoleVasonova, Inc. · 20111cites it

What has FDA decided for it lately?

  • K123813Vascular Positioning System (VPS) G4 ConsoleVasonova, Inc. · 20131 recall
  • K103260Vascular Positioning System (VPS System) ConsoleVasonova, Inc. · 2011
  • K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 20114 recalls
  • K091924VPS CatheterVasonova, Inc. · 2009
  • K083920Flowpicc CatheterVasonova, Inc. · 2009
  • K082481Flowpicc CatheterVasonova, Inc. · 2008
  • K081626Flowpicc ConsoleVasonova, Inc. · 2008
  • K081625Flowpicc StyletVasonova, Inc. · 2008

All 8 as Vasonova, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K103255Arrow (R) VPS (R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous…Jun 1, 2017Class II
  • K103255Arrow (R) VPS (R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central…Apr 28, 2017Class II
  • K042126PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic…Jul 30, 2015Class II
  • K073451Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component…Jul 30, 2015Class II
  • K123813VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C…Mar 30, 2015Class II