Cleared Traditional

K915225 - MEGACART
(FDA 510(k) Clearance)

K915225 · Siemens Burdick, Inc. · Cardiovascular

Jul 1992

Decision

224d

Days

—

Risk

K915225 is an FDA 510(k) clearance for the MEGACART..

Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on July 1, 1992, 224 days after receiving the submission on November 20, 1991.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number	K915225 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 1991
Decision Date	July 01, 1992
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF