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FDA 510(k)

CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR

K-Number: K063349 · 2007-02-16

ApplicantCormatrix Cardiovascular, Inc.
Decision Date2007-02-16
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR 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 2007-02-16 under 510(k) number K063349. 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 PATCH FOR CARDIAC TISSUE REPAIR?

CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR is a medical device that received FDA 510(k) clearance on 2007-02-16. The listed applicant is Cormatrix Cardiovascular, Inc.. The 510(k) number is K063349.

When did CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR receive FDA 510(k) clearance?

CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR received FDA 510(k) clearance on 2007-02-16, under 510(k) number K063349.

Who is the listed applicant for CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR?

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 PATCH FOR CARDIAC TISSUE REPAIR?

The FDA product code for CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR is DXZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)K152127CorMatrix TykeK111187PATCH, PLEDGET AND INTRACARDIACK051405REGENSIS PERICARDIAL PATCH

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.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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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