510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893678Substantially Equivalent

Duran Flexible Annuloplasty Ring & Obturator H601h

Medtronic Blood Systems, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893678 is the FDA 510(k) clearance record for DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H, a class II device, cleared for Medtronic Blood Systems, Inc. on under FDA product code KRH (Ring, Annuloplasty). FDA records list 15 510(k) clearances for Medtronic Blood Systems, Inc., from to . As of , FDA records show no recalls naming K893678.

Clearance record

Decision date
Received
(195 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Blood Systems, Inc. 7000 Central Ave., NE, Minneapolis MN
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