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Firefighter Pro PTCA Balloon Catheter

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

510(k) K252116Ref RF4015

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

9 Jan 2028

CE MDR certificate

FDA recalls

None found

in data synced 26 Oct 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

510(k) K252116↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252116 Date7 Apr 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number69421803C0B09AY Basic UDI-DI 06942180398734UDI-DIDate14 Nov 2025RegisteredStatusActive
European UnionCE/MDD EUDAMED Number69421803C0B09AY Basic UDI-DI 06942180398734UDI-DIDate14 Nov 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Trade Name
Firefighter
Device Name
Firefighter PTCA Ballnoon Catheter
Model / Reference
RF4015
Primary DI / UDI-DI
06942180398734
Basic UDI-DI
69421803C0B09AY
510(k) Number
FDA Product Code
LOX
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III EUDAMED
Class II 510(k)
Regulation
21 CFR Part 870.5100
EU market of registration
Italy
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class III
510(k)
Class II

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 Pro PTCA Balloon Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter, designed for the dilation of coronary arteries to restore blood flow in patients with obstructive coronary artery disease. It is classified as a Class II medical device and used in interventional cardiology procedures to treat stenotic lesions within coronary vessels.

This catheter is supplied sterile and intended for single-use in controlled clinical settings such as cardiac catheterization labs. It is compatible with standard angiography equipment and adheres to MRI safety guidelines for external use. Available in multiple reference codes and sizes, it requires proper storage under sterile conditions and is authorized under FDA 510(k) clearance, MDD, and MDR compliance. No reusable components are specified.

Other devices from Shanghai MicroPort Medical (Group) Co., Ltd.

  • Foxtrot Nc

    Class III

  • Foxtrot Pro

    Class III

  • Foxtrot Nc

    Class III

  • Foxtrot Nc

    Class III

  • Foxtrot Nc

    Class III

  • Foxtrot Nc

    Class III

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

Questions

AI-generated answers, 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.

  • What is the Firefighter Pro PTCA Balloon Catheter used for?

    The Firefighter Pro PTCA Balloon Catheter is designed for the dilation of coronary arteries to restore blood flow in patients with obstructive coronary artery disease during interventional cardiology procedures.

  • Is the Firefighter Pro PTCA Balloon Catheter reusable or single-use?

    The catheter is supplied sterile and intended for single-use in controlled clinical settings such as cardiac catheterization labs, with no reusable components specified.

  • What sizes and models of the Firefighter Pro PTCA Balloon Catheter are available?

    The catheter is available in multiple reference codes and sizes to accommodate various clinical needs, though specific dimensions are not detailed in the provided information.

  • How should the Firefighter Pro PTCA Balloon Catheter be stored?

    The catheter requires proper storage under sterile conditions to maintain its integrity and safety for clinical use.

  • What regulatory approvals does the Firefighter Pro PTCA Balloon Catheter have?

    The device is authorized under FDA 510(k) clearance, MDD, and MDR compliance, indicating it meets regulatory requirements for safety and performance.

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No