510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871596Substantially Equivalent

Ionescu-Shiley Pericardial Xenograft (Isu)

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

K871596 is the FDA 510(k) clearance record for IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU), a class I device, cleared for Shiley, Inc. on under FDA product code DTJ (Holder, Heart-Valve, Prosthesis). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K871596.

Clearance record

Decision date
Received
(52 days to decision)
Product code
DTJ Holder, Heart-Valve, Prosthesis
Regulation
21 CFR 870.3935
Device class
Class I
Review panel
Cardiovascular
Applicant
Shiley, Inc. 17600 Gillette Ave., Irvine CA
Third party review
No

Clearances, product code DTJ

Trailing 12 months

FDA records hold no clearances under product code DTJ in the trailing twelve months.

FDA records show no clearances under product code DTJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260