510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914602Substantially Equivalent

Duran Flex Annuloplasty Ring/obtur H601h, Modified

The Heart Valve Div. Medtronic Cardiovascular Surg, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914602 is the FDA 510(k) clearance record for DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED, a class II device, cleared for The Heart Valve Div. Medtronic Cardiovascular Surg on under FDA product code KRH (Ring, Annuloplasty). FDA records list 5 510(k) clearances for The Heart Valve Div. Medtronic Cardiovascular Surg, from to . As of , FDA records show no recalls naming K914602.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
The Heart Valve Div. Medtronic Cardiovascular Surg 7000 Central Ave., NE, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code KRH

Trailing 12 months
2 clearances under product code KRH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260