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FDA 510(k)

FOGARTY VALVULOTOME MODEL 700091

K-Number: K965137 · 1997-06-04

ApplicantBaxter Edwards
Decision Date1997-06-04
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOGARTY VALVULOTOME MODEL 700091 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Edwards. It received FDA 510(k) clearance on 1997-06-04 under 510(k) number K965137. The device is classified under product code MGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOGARTY VALVULOTOME MODEL 700091?

FOGARTY VALVULOTOME MODEL 700091 is a medical device that received FDA 510(k) clearance on 1997-06-04. The listed applicant is Baxter Edwards. The 510(k) number is K965137.

When did FOGARTY VALVULOTOME MODEL 700091 receive FDA 510(k) clearance?

FOGARTY VALVULOTOME MODEL 700091 received FDA 510(k) clearance on 1997-06-04, under 510(k) number K965137.

Who is the listed applicant for FOGARTY VALVULOTOME MODEL 700091?

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

What is the FDA product code for FOGARTY VALVULOTOME MODEL 700091?

The FDA product code for FOGARTY VALVULOTOME MODEL 700091 is MGZ.

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Other records listing Baxter Edwards 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.

K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FDK981909BAXTER HEMOSTASIS VALVE INTRODUCERSK980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSMK964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETERK9526384.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[

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Related Devices (Code: MGZ)

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.

K260188LimFlow VectorLimFlow, Inc.K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.K221902LimFlow VectorLimFlow, Inc.K190267EZE SIT ValvulotomeLemaitre VascularK132047LEMILLS VALVULOTOMELeMaitre Vascular, Inc.K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.

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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