Cleared Special

PhotoFix Decellularized Bovine Pericardium

K183635 · Cryolife, Inc. · Cardiovascular

Feb 2019

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K183635 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 February 14, 2019, 50 days after receiving the submission on December 26, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K183635 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2018
Decision Date	February 14, 2019
Days to Decision	50 days
Submission Type	Special
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.