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FDA 510(k)

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM

K-Number: K993288 · 1999-12-29

ApplicantSulzer Carbomedics, Inc.
Decision Date1999-12-29
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Carbomedics, Inc.. It received FDA 510(k) clearance on 1999-12-29 under 510(k) number K993288. 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 SULZER CARBOMEDICS CARDIOFIX PERICARDIUM?

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM is a medical device that received FDA 510(k) clearance on 1999-12-29. The listed applicant is Sulzer Carbomedics, Inc.. The 510(k) number is K993288.

When did SULZER CARBOMEDICS CARDIOFIX PERICARDIUM receive FDA 510(k) clearance?

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM received FDA 510(k) clearance on 1999-12-29, under 510(k) number K993288.

Who is the listed applicant for SULZER CARBOMEDICS CARDIOFIX PERICARDIUM?

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

What is the FDA product code for SULZER CARBOMEDICS CARDIOFIX PERICARDIUM?

The FDA product code for SULZER CARBOMEDICS CARDIOFIX PERICARDIUM is DXZ.

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Other records listing Sulzer Carbomedics, 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.

K023185ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800K013022SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESISK021051ANNULOFLO SYSTEM, MITRAL MODEL AR700K002007SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESISK992056ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800K974648SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

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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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