Cleared Traditional

PhotoFix Decellularized Bovine Pericardium

K172085 · Cryolife, Inc. · Cardiovascular

Dec 2017

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K172085 is an FDA 510(k) clearance for the PhotoFix Decellularized Bovine Pericardium, a Intracardiac Patch Or Pledget, Biologically Derived (Class II — Special Controls, product code PSQ), submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on December 4, 2017, 146 days after receiving the submission on July 11, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K172085 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2017
Decision Date	December 04, 2017
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PSQ — Intracardiac Patch Or Pledget, Biologically Derived
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.3470
Definition	To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature.