510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965214Substantially Equivalent

Coeur Front Load Injector Retrofit Kit (C859-0002)

Coeur Laboratories, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965214 is the FDA 510(k) clearance record for COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002), a class II device, cleared for Coeur Laboratories, Inc. on under FDA product code DTX (Gas Control Unit, Cardiopulmonary Bypass). FDA records list 10 510(k) clearances for Coeur Laboratories, Inc., from to . As of , FDA records show no recalls naming K965214.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DTX Gas Control Unit, Cardiopulmonary Bypass
Regulation
21 CFR 870.4300
Device class
Class II
Review panel
Cardiovascular
Applicant
Coeur Laboratories, Inc. 5301 Depature Dr., Raleigh NC
510(k) summary
Summary
Third party review
No

Clearances, product code DTX

Trailing 12 months

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

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