Cleared Traditional

K960965 - FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
(FDA 510(k) Clearance)

K960965 · Coeur Laboratories, Inc. · Cardiovascular

Sep 1996

Decision

185d

Days

Class 2

Risk

K960965 is an FDA 510(k) clearance for the FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211. This device is classified as a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT).

Submitted by Coeur Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on September 12, 1996, 185 days after receiving the submission on March 11, 1996.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K960965 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 1996
Decision Date	September 12, 1996
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement