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FDA 510(k)

PERICARDIAL PATCH

K-Number: K833763 · 1984-11-01

ApplicantAmerican Edwards Laboratories
Decision Date1984-11-01
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERICARDIAL PATCH is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1984-11-01 under 510(k) number K833763. 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 PERICARDIAL PATCH?

PERICARDIAL PATCH is a medical device that received FDA 510(k) clearance on 1984-11-01. The listed applicant is American Edwards Laboratories. The 510(k) number is K833763.

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

PERICARDIAL PATCH received FDA 510(k) clearance on 1984-11-01, under 510(k) number K833763.

Who is the listed applicant for PERICARDIAL PATCH?

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

What is the FDA product code for PERICARDIAL PATCH?

The FDA product code for PERICARDIAL PATCH is DXZ.

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Other records listing American Edwards Laboratories as applicant

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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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