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510(k) K162579

VascuCel by Admedus Regen Pty, Ltd. — Product Code DXZ

K162579 is an FDA 510(k) premarket notification submitted by Admedus Regen Pty, Ltd. for the device "VascuCel". The FDA issued a decision of Substantially Equivalent on October 14, 2016. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), 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
October 14, 2016
Date Received
September 15, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

Other clearances by Admedus Regen Pty, Ltd.

  • K200566 — ADAPT Tissue (April 3, 2020)
  • K170951 — CardioCel 3D (April 28, 2017)

Other clearances for product code DXZ

  • K240775 — PeriBeam® Pericardial Membrane (April 18, 2025)
  • K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (July 8, 2020)
  • K162506 — PhotoFix Decellularized Bovine Pericardium (March 9, 2017)
  • K152127 — CorMatrix Tyke (February 4, 2016)
  • K151865 — PremiPatch PTFE Pledget (October 27, 2015)
  • K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (January 7, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (July 15, 2014)
  • K130872 — CARDIOCEL (January 30, 2014)
  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)

FDA data resources