510(k) Report

FDA applicant

Accessclosure, Inc.

Santa Clara, CA1 decision2015–20151 recall

FDA records 1 decision for Accessclosure, Inc. (Santa Clara, CA) in 2015: 1 510(k) clearance. All are in product code MJN (Catheter, Intravascular Occluding, Temporary). Its devices cite 2 predicates, 0 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 Accessclosure, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2015high 1 (2016) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Accessclosure, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Accessclosure, 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?

  • MJNCatheter, Intravascular Occluding, Temporary1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K143613PaxWire Occlusion Balloon SystemAccessclosure, Inc. · 20151 recall

The one decision as Accessclosure, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K143613The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle…Oct 6, 2016Class II