Cleared Traditional

K913397 - MEGA ANGIOGRAM KIT
(FDA 510(k) Clearance)

K913397 · Mega Medical, Inc. · Cardiovascular

Oct 1991

Decision

93d

Days

Class 2

Risk

K913397 is an FDA 510(k) clearance for the MEGA ANGIOGRAM KIT, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Mega Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on October 31, 1991, 93 days after receiving the submission on July 30, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K913397 FDA.gov
FDA Decision	Cleared SEKD
Date Received	July 30, 1991
Decision Date	October 31, 1991
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement