510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900339Substantially Equivalent

Hand-Held Intracardiac Suckers W/ergonomic Handles

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

K900339 is the FDA 510(k) clearance record for HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES, a class II device, cleared for Shiley, Inc. on under FDA product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K900339.

Clearance record

Decision date
Received
(64 days to decision)
Product code
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Regulation
21 CFR 870.4420
Device class
Class II
Review panel
Cardiovascular
Applicant
Shiley, Inc. 17600 Gillette Ave., Irvine CA
Third party review
No

Clearances, product code DTS

Trailing 12 months

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

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