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FDA 510(k)

VascuCel

K-Number: K162579 · 2016-10-14

ApplicantAdmedus Regen Pty, Ltd.
Decision Date2016-10-14
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VascuCel is a medical device manufactured by Admedus Regen Pty, Ltd.. It received FDA 510(k) clearance on 2016-10-14 under approval number K162579. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VascuCel?

VascuCel is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Admedus Regen Pty, Ltd.. The 510(k) number is K162579.

When was VascuCel approved by the FDA?

VascuCel received FDA 510(k) clearance on 2016-10-14, under approval number K162579.

What company makes VascuCel?

VascuCel is manufactured by Admedus Regen Pty, Ltd..

What is the FDA product code for VascuCel?

The FDA product code for VascuCel is DXZ.

Other Devices by Admedus Regen Pty, Ltd.

K170951CardioCel 3D K200566ADAPT Tissue

Related Devices (Code: DXZ)

K152127CorMatrix TykeCormatrix Cardiovascular, Inc. K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd. K240775PeriBeam® Pericardial MembraneTamabio

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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