Skip to content

Marinr Series Ep Diagnosti Catheters

by Medtronic Cardiorhythm

510(k) K951347

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951347 Date10 May 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 27 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 device is a catheter, electrode recording, or probe, electrode recording, used for cardiovascular applications. It is part of the Marinr Series EP diagnostic catheters manufactured by Medtronic Cardiorhythm.

It received FDA 510(k) clearance under K951347 on May 10, 1995, with product code DRF and regulation number 870.1220. The device is classified as Class II and is substantially equivalent to a predicate device.

Other devices from Medtronic Cardiorhythm