510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K813276Substantially Equivalent

Ionescu-Shiley Valve Holder & Handle

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

K813276 is the FDA 510(k) clearance record for IONESCU-SHILEY VALVE HOLDER & HANDLE, 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 K813276.

Clearance record

Decision date
Received
(17 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. 4221 Richmond Rd., NW, Walker MI
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