510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K872161Substantially Equivalent

Dideco-Shiley Preassembled Surgical Wash Set

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

K872161 is the FDA 510(k) clearance record for DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET, a class II device, cleared for Shiley, Inc. on under FDA product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K872161.

Clearance record

Decision date
Received
(69 days to decision)
Product code
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Regulation
21 CFR 870.4290
Device class
Class II
Review panel
Cardiovascular
Applicant
Shiley, Inc. 17600 Gillette Ave., Irvine CA
Third party review
No

Clearances, product code DTL

Trailing 12 months

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

FDA records show no clearances under product code DTL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTL, 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