Cleared Special

CardioCel 3D

K170951 · Admedus Regen Pty, Ltd. · Cardiovascular

Apr 2017

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K170951 is an FDA 510(k) clearance for the CardioCel 3D, a Intracardiac Patch Or Pledget, Biologically Derived (Class II — Special Controls, product code PSQ), submitted by Admedus Regen Pty, Ltd. (Malaga, AU). The FDA issued a Cleared decision on April 28, 2017, 28 days after receiving the submission on March 31, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K170951 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2017
Decision Date	April 28, 2017
Days to Decision	28 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.