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FDA 510(k)

REGENSIS PERICARDIAL PATCH

K-Number: K051405 · 2005-08-31

ApplicantCormatrix Cardiovascular, Inc.
Decision Date2005-08-31
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REGENSIS PERICARDIAL PATCH 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 2005-08-31 under 510(k) number K051405. 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 REGENSIS PERICARDIAL PATCH?

REGENSIS PERICARDIAL PATCH is a medical device that received FDA 510(k) clearance on 2005-08-31. The listed applicant is Cormatrix Cardiovascular, Inc.. The 510(k) number is K051405.

When did REGENSIS PERICARDIAL PATCH receive FDA 510(k) clearance?

REGENSIS PERICARDIAL PATCH received FDA 510(k) clearance on 2005-08-31, under 510(k) number K051405.

Who is the listed applicant for REGENSIS PERICARDIAL PATCH?

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 REGENSIS PERICARDIAL PATCH?

The FDA product code for REGENSIS PERICARDIAL PATCH 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.

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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 INTRACARDIACK063349CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR

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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