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FDA 510(k)

PERIPRO PATCH

K-Number: K052416 · 2005-10-25

ApplicantHancock/Jaffe Laboratories
Decision Date2005-10-25
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIPRO PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Hancock/Jaffe Laboratories. It received FDA 510(k) clearance on 2005-10-25 under 510(k) number K052416. 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 PERIPRO PATCH?

PERIPRO PATCH is a medical device that received FDA 510(k) clearance on 2005-10-25. The listed applicant is Hancock/Jaffe Laboratories. The 510(k) number is K052416.

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

PERIPRO PATCH received FDA 510(k) clearance on 2005-10-25, under 510(k) number K052416.

Who is the listed applicant for PERIPRO PATCH?

The FDA 510(k) record lists Hancock/Jaffe Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERIPRO PATCH?

The FDA product code for PERIPRO 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

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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