Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Cormatrix Cardiovascular, Inc.. It received FDA 510(k) clearance on 2016-02-04 under 510(k) 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. The listed applicant is Cormatrix Cardiovascular, Inc.. The 510(k) number is K152127.

When did CorMatrix Tyke receive FDA 510(k) clearance?

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

Who is the listed applicant for CorMatrix Tyke?

The FDA 510(k) record lists Cormatrix Cardiovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CorMatrix Tyke?

The FDA product code for CorMatrix Tyke is DXZ.

Other records listing Cormatrix Cardiovascular, Inc. 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.

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)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.

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.

↑