510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960965Substantially Equivalent

Front Load Injector Turret Model 859-0001/200 Ml Front Load Syringe Model 853-0211

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

K960965 is the FDA 510(k) clearance record for FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211, a class II device, cleared for Coeur Laboratories, Inc. on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list 10 510(k) clearances for Coeur Laboratories, Inc., from to . As of , FDA records show no recalls naming K960965.

Clearance record

Decision date
Received
(185 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Coeur Laboratories, Inc. 5301 Depature Dr., Raleigh NC
510(k) summary
Statement
Third party review
No

Clearances, product code DXT

Trailing 12 months
6 clearances under product code DXT in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DXT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260