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FDA 510(k)

PERI-GUARD PERICARDIAL PATCH

K-Number: K842066 · 1985-12-30

ApplicantGenetic Laboratories, Inc.
Decision Date1985-12-30
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERI-GUARD PERICARDIAL PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Laboratories, Inc.. It received FDA 510(k) clearance on 1985-12-30 under 510(k) number K842066. 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 PERI-GUARD PERICARDIAL PATCH?

PERI-GUARD PERICARDIAL PATCH is a medical device that received FDA 510(k) clearance on 1985-12-30. The listed applicant is Genetic Laboratories, Inc.. The 510(k) number is K842066.

When did PERI-GUARD PERICARDIAL PATCH receive FDA 510(k) clearance?

PERI-GUARD PERICARDIAL PATCH received FDA 510(k) clearance on 1985-12-30, under 510(k) number K842066.

Who is the listed applicant for PERI-GUARD PERICARDIAL PATCH?

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

What is the FDA product code for PERI-GUARD PERICARDIAL PATCH?

The FDA product code for PERI-GUARD 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 Genetic Laboratories, 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.

K842621SUTURE STRIPK821532PERIGUARD 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

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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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