Cleared Traditional

K152127 - CorMatrix Tyke
(FDA 510(k) Clearance)

K152127 · Cormatrix Cardiovascular, Inc. · Cardiovascular

Feb 2016

Decision

188d

Days

Class 2

Risk

K152127 is an FDA 510(k) clearance for the CorMatrix Tyke, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Cormatrix Cardiovascular, Inc. (Roswell, US). The FDA issued a Cleared decision on February 4, 2016, 188 days after receiving the submission on July 31, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K152127 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2015
Decision Date	February 04, 2016
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF