510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K083835Substantially Equivalent

Attune Adjustable Flexible Annuloplasty Ring Model Afr

Abbott Medical, St.Paul MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083835 is the FDA 510(k) clearance record for ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR, a class II device, cleared for St Jude Medical on under FDA product code KRH (Ring, Annuloplasty). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K083835.

Clearance record

Decision date
Received
(31 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
St Jude Medical 177 E. County Rd. B, St.Paul MN
510(k) summary
Summary PDF
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