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Reflexion Spiral Variable Radius Catheter, Model 402804

by St Jude Medical

510(k) K062251

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062251 Date20 Oct 2006ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DRF
Device class
Class II
Regulation
21 CFR Part 870.1220
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Reflexion Spiral Variable Radius Catheter is a flexible, asymmetric, bi-directional, radiopaque loop electrophysiology catheter used to map the atrial regions of the heart. It features a polymer shaft with platinum electrodes and a ComfortGrip proximal handle.

This catheter is supplied in 7 French gauge size and is distributed commercially. It is a Class II device cleared by the FDA under 510(k) K062251 for cardiovascular procedures. The device is radiopaque and designed for electrophysiology applications.

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