510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170951Substantially Equivalent

CardioCel 3D

Admedus Regen Pty, Ltd., Malaga, AU / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170951 is the FDA 510(k) clearance record for CardioCel 3D, a class II device, cleared for Admedus Regen Pty, Ltd. on under FDA product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived). FDA's definition for product code PSQ reads: "To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature". FDA records list 3 510(k) clearances for Admedus Regen Pty, Ltd., from to . As of , FDA records show no recalls naming K170951.

Clearance record

Decision date
Received
(28 days to decision)
Product code
PSQ Intracardiac Patch Or Pledget, Biologically Derived
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Admedus Regen Pty, Ltd. 26 Harris Rd., Malaga, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PSQ

Trailing 12 months

FDA records hold no clearances under product code PSQ in the trailing twelve months.

FDA records show no clearances under product code PSQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PSQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260