DeviceClearance

Product code PSQ— Cardiovascular

PhotoFix Decellularized Bovine Pericardium

Classification name
Intracardiac Patch Or Pledget, Biologically Derived
Device class
Class 2
Regulation
21 CFR 870.3470
Advisory panel
Cardiovascular
Total cleared
11
First cleared
Most recent

FDA classification definition

“To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.”

— U.S. Food and Drug Administration, device classification record for product code PSQ under 21 CFR 870.3470, via openFDA

Market context for product code PSQ

FDA has cleared 11 devices under product code PSQ between 2017 and 2022, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PSQ

Recent clearances under product code PSQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.