Cleared Special

VascuCel

K162579 · Admedus Regen Pty, Ltd. · Cardiovascular

Oct 2016

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K162579 is an FDA 510(k) clearance for the VascuCel, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Admedus Regen Pty, Ltd. (Malaga, AU). The FDA issued a Cleared decision on October 14, 2016, 29 days after receiving the submission on September 15, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K162579 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2016
Decision Date	October 14, 2016
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF