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FDA 510(k)

CorMatrix Tyke

K-Number: K152127 · 2016-02-04

ApplicantCormatrix Cardiovascular, Inc.
Decision Date2016-02-04
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CorMatrix Tyke is a medical device manufactured by Cormatrix Cardiovascular, Inc.. It received FDA 510(k) clearance on 2016-02-04 under approval number K152127. 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 CorMatrix Tyke?

CorMatrix Tyke is a medical device that received FDA 510(k) clearance on 2016-02-04. It is manufactured by Cormatrix Cardiovascular, Inc.. The 510(k) number is K152127.

When was CorMatrix Tyke approved by the FDA?

CorMatrix Tyke received FDA 510(k) clearance on 2016-02-04, under approval number K152127.

What company makes CorMatrix Tyke?

CorMatrix Tyke is manufactured by Cormatrix Cardiovascular, Inc..

What is the FDA product code for CorMatrix Tyke?

The FDA product code for CorMatrix Tyke is DXZ.

Other Devices by Cormatrix Cardiovascular, Inc.

K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)

Related Devices (Code: DXZ)

K162579VascuCelAdmedus Regen Pty, Ltd. 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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