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Duran Flex Annuloplasty Ring/Obtur H601H, Modified

by The Heart Valve Div. Medtronic Cardiovascular Surg

510(k) K914602

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 NumberK914602 Date22 Nov 1991ClearedStatusActive

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  • Withdrawn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
KRH
Device Class
Class II
Regulation
21 CFR Part 870.3800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Duran Flex Annuloplasty Ring/Obturator H601H is a flexible annuloplasty ring designed for mitral or tricuspid valve reconstruction. It is intended to correct valvular insufficiency by reinforcing the annulus and restoring annular geometry during surgical repair.

This device is supplied sterile and intended for single-use in cardiac surgical procedures. It is classified as a Class II medical device under FDA regulation 870.3800 and has received FDA 510(k) clearance (K914602). The ring is paired with an obturator for implantation and is available in a modified configuration for precise fitting.

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