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FDA 510(k)

PFA PATCH

K-Number: K041736 · 2005-01-13

ApplicantPeritec Biosciences, LLC
Decision Date2005-01-13
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PFA PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Peritec Biosciences, LLC. It received FDA 510(k) clearance on 2005-01-13 under 510(k) number K041736. 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 PFA PATCH?

PFA PATCH is a medical device that received FDA 510(k) clearance on 2005-01-13. The listed applicant is Peritec Biosciences, LLC. The 510(k) number is K041736.

When did PFA PATCH receive FDA 510(k) clearance?

PFA PATCH received FDA 510(k) clearance on 2005-01-13, under 510(k) number K041736.

Who is the listed applicant for PFA PATCH?

The FDA 510(k) record lists Peritec Biosciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PFA PATCH?

The FDA product code for PFA PATCH is DXZ.

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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

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

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