510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992056Substantially Equivalent

Annuloflex Annuloplasty System, Model Af800

Sulzer Carbomedics, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992056 is the FDA 510(k) clearance record for ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800, a class II device, cleared for Sulzer Carbomedics, Inc. on under FDA product code KRH (Ring, Annuloplasty). FDA records list 8 510(k) clearances for Sulzer Carbomedics, Inc., from to . As of , FDA records show no recalls naming K992056.

Clearance record

Decision date
Received
(116 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
Sulzer Carbomedics, Inc. 1300 E. Anderson Ln., Austin TX
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