Cleared Traditional

K050371 - MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
(FDA 510(k) Clearance)

K050371 · Medrad, Inc. · Cardiovascular

Jun 2005

Decision

113d

Days

Class 2

Risk

K050371 is an FDA 510(k) clearance for the MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on June 7, 2005, 113 days after receiving the submission on February 14, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K050371 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2005
Decision Date	June 07, 2005
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF