Cleared Traditional

K172085 - PhotoFix Decellularized Bovine Pericardium (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172085 · Cryolife, Inc. · Cardiovascular device
Dec 2017
Decision
146d
Days
Class 2
Risk

K172085 is an FDA 510(k) clearance for the PhotoFix Decellularized Bovine Pericardium. Classified as Intracardiac Patch Or Pledget, Biologically Derived (product code PSQ), Class II - Special Controls.

Submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on December 4, 2017 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K172085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 140d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSQ Intracardiac Patch Or Pledget, Biologically Derived
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.