Cleared Traditional

CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip

K170431 · Coeur, Inc. · Cardiovascular

Aug 2017

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K170431 is an FDA 510(k) clearance for the CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on August 18, 2017, 186 days after receiving the submission on February 13, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K170431 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2017
Decision Date	August 18, 2017
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF