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FDA 510(k)

PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE

K-Number: K972201 · 1998-04-14

ApplicantSulzer Carbomedics, Inc.
Decision Date1998-04-14
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE 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 1998-04-14 under 510(k) number K972201. 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 PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE?

PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE is a medical device that received FDA 510(k) clearance on 1998-04-14. The listed applicant is Sulzer Carbomedics, Inc.. The 510(k) number is K972201.

When did PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE receive FDA 510(k) clearance?

PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE received FDA 510(k) clearance on 1998-04-14, under 510(k) number K972201.

Who is the listed applicant for PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE?

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 PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE?

The FDA product code for PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE 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 PROSTHESISK993288SULZER CARBOMEDICS CARDIOFIX PERICARDIUMK992056ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

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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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