PaxWire Occlusion Balloon System— 510(k) K143613

Name: FDA 510(k) clearance K143613
Creator: U.S. Food and Drug Administration
Published: 2015-08-14

Substantially Equivalent

Accessclosure, Inc.

FDA 510(k) clearance K143613 for PaxWire Occlusion Balloon System, Substantially Equivalent on 2015-08-14. Applicant: Accessclosure, Inc.. Device class: 2.

Clearance details

Applicant: Accessclosure, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2014-12-19
Decision date: 2015-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MJN

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K243795 — pREBOA-PRO Catheter2025-09-05
K251358 — Bridge Plus Occlusion Balloon (590-002)2025-06-24
K221294 — preCARDIA Occlusion System2023-06-30
K214060 — LANDMARK REBOA Catheter2022-09-19
K211610 — Fogarty Occlusion Catheter2022-02-14

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K143613

K-number listed on FDA's recall record

Z-0297-2017 — The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.Class II·Terminated·AccessClosure, Inc., A Cardinal Health Company·20161006

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143613.

Data sourced from openFDA. This site is unofficial and independent of the FDA.