510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K801879Substantially Equivalent

Puig Massana-Shiley Annuloplasty Ring

Shiley, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801879 is the FDA 510(k) clearance record for PUIG MASSANA-SHILEY ANNULOPLASTY RING, a class II device, cleared for Shiley, Inc. on under FDA product code KRH (Ring, Annuloplasty). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K801879.

Clearance record

Decision date
Received
(132 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
Shiley, Inc. 803 N. Front St. Suite 3, Mchenry IL
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