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Firefighter NC Pro PTCA Balloon Catheter

by Shanghai MicroPort Medical (Group) Co., Ltd.

510(k) K223189

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223189↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223189 Date21 Jul 2023ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LOX
Device Class
Class II
Regulation
21 CFR Part 870.5100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Firefighter NC Pro PTCA Balloon Catheter is a Transluminal Coronary Angioplasty, Percutaneous Catheter designed for coronary artery dilation. It employs a compliant balloon to mechanically widen narrowed or obstructed coronary arteries, restoring blood flow and improving myocardial perfusion in patients with coronary artery disease.

This device is intended for single-use in interventional cardiology settings, supplied sterile and packaged for aseptic handling. It is classified as a Class II medical device under FDA regulations (870.5100) and has received FDA 510(k) clearance and MDD authorization. Available in multiple reference codes and sizes, it must be stored according to manufacturer instructions to maintain sterility and performance.

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See all devices from Shanghai MicroPort Medical (Group) Co., Ltd. →