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Franz Steerable Combination Catheter

by Ep Technologies, Inc. 510(k)

Active United States

510(k) K903880

Overview

The Franz Steerable Combination Catheter is a cardiovascular catheter designed for electrode recording procedures. It is a Class II medical device that combines steerable functionality with electrode recording capabilities.

This catheter is manufactured by Ep Technologies, Inc. and is supplied as a single-use device. It received FDA 510(k) clearance with K number K903880 on October 12, 1990, and is regulated under product code DRF. The device is not indicated for MRI use and requires appropriate storage conditions as specified by the manufacturer.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903880 Date12 Oct 1990ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Franz(Tm) Steerable Combination Catheter
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

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Questions

  • What is the Franz Steerable Combination Catheter used for?

    The Franz Steerable Combination Catheter is designed for cardiovascular electrode recording procedures, combining steerable functionality with electrode recording capabilities in a Class II medical device.

  • Is the Franz Steerable Combination Catheter reusable or single-use?

    The Franz Steerable Combination Catheter is supplied as a single-use device and should not be reused according to the manufacturer's specifications.

  • What regulatory approvals does the Franz Steerable Combination Catheter have?

    The Franz Steerable Combination Catheter received FDA 510(k) clearance with K number K903880 on October 12, 1990, and is regulated under product code DRF as a Class II medical device.

  • Can the Franz Steerable Combination Catheter be used in MRI procedures?

    No, the Franz Steerable Combination Catheter is not indicated for MRI use and should only be used according to the manufacturer's specified conditions.