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FDA 510(k)

HANCOCK PERICARDIAL PATCH

K-Number: K840262 · 1984-05-30

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1984-05-30
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HANCOCK PERICARDIAL PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1984-05-30 under 510(k) number K840262. 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 HANCOCK PERICARDIAL PATCH?

HANCOCK PERICARDIAL PATCH is a medical device that received FDA 510(k) clearance on 1984-05-30. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K840262.

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

HANCOCK PERICARDIAL PATCH received FDA 510(k) clearance on 1984-05-30, under 510(k) number K840262.

Who is the listed applicant for HANCOCK PERICARDIAL PATCH?

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

What is the FDA product code for HANCOCK PERICARDIAL PATCH?

The FDA product code for HANCOCK PERICARDIAL PATCH is DXZ.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840532HEMOPERFUSION SYSTEM TP-400K840146EXP* 700 PARALLEL PLATE DIALYZERK840057EXP* 500 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLERK831423THERAPEUTIC EXCHANGE SYSTEM

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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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