Cleared Traditional

K072886 - MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
(FDA 510(k) Clearance)

K072886 · Medrad, Inc. · Cardiovascular

Dec 2007

Decision

73d

Days

Class 2

Risk

K072886 is an FDA 510(k) clearance for the MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on December 21, 2007, 73 days after receiving the submission on October 9, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K072886 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2007
Decision Date	December 21, 2007
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF