510(k) Report

FDA applicant

Cardiva Medical, Inc.

Sunnyvale, CA9 decisions2004–20130 recalls

FDA records 9 decisions for Cardiva Medical, Inc. (Sunnyvale, CA) from 2004 to 2013: 7 510(k) clearances and 2 original PMA approvals. Most are in product codes DXC (Clamp, Vascular) and MGB (Device, Hemostasis, Vascular). Its devices cite 12 predicates, 8 of them its own earlier devices. No 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 Cardiva Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2007: 22009: 12010: 12013: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • DXCClamp, Vascular7decisions
  • MGBDevice, Hemostasis, Vascular2decisions

Whose devices does it build on?

Its devices cite 12 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K041486Vasostasis Vascular Closure SystemCardiva Medical, Inc. · 20043cite it
  • K070485Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc. · 20072cite it
  • K072297Boomerang Catalyst/Boomerang Catalyst II SystemCardiva Medical, Inc. · 20072cite it
  • K051817Boomerang Closurewire Vascular Closure SystemCardiva Medical, Inc. · 20061cites it
  • K061075Boomerang WireCardiva Medical, Inc. · 20061cites it
  • K082930Cardiva Catalyst Iii System with Protamine SulfateCardiva Medical, Inc. · 20091cites it

What has FDA decided for it lately?

  • K130124Catalyst II and IiiCardiva Medical, Inc. · 2013
  • P120016Vascade Vascular Closure SystemCardiva Medical, Inc. · 2013
  • P080029Quick-Close Vascular Suturing System (Quick-Close System)Cardiva Medical, Inc. · 2010
  • K082930Cardiva Catalyst Iii System with Protamine SulfateCardiva Medical, Inc. · 2009
  • K072297Boomerang Catalyst/Boomerang Catalyst II SystemCardiva Medical, Inc. · 2007
  • K070485Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc. · 2007
  • K051817Boomerang Closurewire Vascular Closure SystemCardiva Medical, Inc. · 2006
  • K061075Boomerang WireCardiva Medical, Inc. · 2006

All 9 as Cardiva Medical, Inc. →