Cleared Special

ADAPT Tissue

K200566 · Admedus Regen Pty, Ltd. · Cardiovascular

Apr 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K200566 is an FDA 510(k) clearance for the ADAPT Tissue, 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 3, 2020, 30 days after receiving the submission on March 4, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K200566 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2020
Decision Date	April 03, 2020
Days to Decision	30 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.