510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K032920Substantially Equivalent

The Coeur Injector Adaptor/pressure Jacket, Model C859-6003

Coeur Medical, Washington NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032920 is the FDA 510(k) clearance record for THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003, a class II device, cleared for Coeur Medical on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list one 510(k) clearance for Coeur Medical. As of , FDA records show no recalls naming K032920.

Clearance record

Decision date
Received
(85 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Coeur Medical 209 Creekside Dr., Washington 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