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Serranator PTA Serration Balloon Catheter

by Cagent Vascular, LLC EUDAMED510(k)

Active European Union and United States

510(k) K220704

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK220704 Date4 May 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PNO
Device Class
Class II
Regulation
21 CFR Part 870.1250
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 Serranator PTA Serration Balloon Catheter is a Percutaneous, Cutting/Scoring Catheter designed for peripheral angioplasty interventions. It incorporates serrated elements along the balloon surface to facilitate controlled vessel expansion, optimizing lumen gain while minimizing dissection and recoil during treatment.

This device is supplied as a single-use, non-sterile product intended for use in cardiovascular procedures. It is classified as a Class II medical device under FDA regulations (21 CFR 870.1250) and has received FDA 510K clearance and MDR authorization. Sizes and reference codes are specified in the product’s technical documentation, with no additional MRI safety or sterility requirements stated.

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