FDA 510(k)

VascuCel

K-Number: K162579 · 2016-10-14

Decision Date2016-10-14

Product CodeDXZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VascuCel is the device name listed in this FDA 510(k) record. The listed applicant is Admedus Regen Pty, Ltd.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) 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. The listed applicant is Admedus Regen Pty, Ltd.. The 510(k) number is K162579.

When did VascuCel receive FDA 510(k) clearance?

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

Who is the listed applicant for VascuCel?

The FDA 510(k) record lists Admedus Regen Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VascuCel?

The FDA product code for VascuCel is DXZ.

Other records listing Admedus Regen Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200566ADAPT Tissue K170951CardioCel 3D

Related Devices (Code: DXZ)

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

Official Source

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