510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K984435Substantially Equivalent

Medtronic Khonsari Annuloplasty Band, Model H609m

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

K984435 is the FDA 510(k) clearance record for MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M, a class II device, cleared for Medtronic Vascular on under FDA product code KRH (Ring, Annuloplasty). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K984435.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Vascular 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 November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260