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510(k) K170951

CardioCel 3D by Admedus Regen Pty, Ltd. — Product Code PSQ

K170951 is an FDA 510(k) premarket notification submitted by Admedus Regen Pty, Ltd. for the device "CardioCel 3D". The FDA issued a decision of Substantially Equivalent on April 28, 2017. The device falls under product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived), a Class II device regulated under 21 CFR 870.3470. Admedus Regen Pty, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2017
Date Received
March 31, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracardiac Patch Or Pledget, Biologically Derived
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

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

Other clearances by Admedus Regen Pty, Ltd.

  • K200566 — ADAPT Tissue (April 3, 2020)
  • K162579 — VascuCel (October 14, 2016)

Other clearances for product code PSQ

  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K221032 — Vascu-Guard Vascular Repair Patch (October 19, 2022)
  • K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix (December 21, 2021)
  • K200566 — ADAPT Tissue (April 3, 2020)
  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • K191734 — MatriStem UBM Pericardial Patch (November 22, 2019)
  • K183635 — PhotoFix Decellularized Bovine Pericardium (February 14, 2019)
  • K181038 — CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm (October 10, 2018)
  • K172085 — PhotoFix Decellularized Bovine Pericardium (December 4, 2017)
  • K172660 — Duravess bovine pericardial vascular patch (November 17, 2017)

FDA data resources