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FDA 510(k)

LEMAITRE VALVULOTOME II

K-Number: K946352 · 1995-06-21

ApplicantVascutech, Inc.
Decision Date1995-06-21
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMAITRE VALVULOTOME II is the device name listed in this FDA 510(k) record. The listed applicant is Vascutech, Inc.. It received FDA 510(k) clearance on 1995-06-21 under 510(k) number K946352. 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 LEMAITRE VALVULOTOME II?

LEMAITRE VALVULOTOME II is a medical device that received FDA 510(k) clearance on 1995-06-21. The listed applicant is Vascutech, Inc.. The 510(k) number is K946352.

When did LEMAITRE VALVULOTOME II receive FDA 510(k) clearance?

LEMAITRE VALVULOTOME II received FDA 510(k) clearance on 1995-06-21, under 510(k) number K946352.

Who is the listed applicant for LEMAITRE VALVULOTOME II?

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

What is the FDA product code for LEMAITRE VALVULOTOME II?

The FDA product code for LEMAITRE VALVULOTOME II is MGZ.

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Other records listing Vascutech, 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.

K001621DARDIK CAROTID SHUNTK992942LEMAITRE OCCLUSION CATHETERK992933LEMAITRE IRRIGATION CATHETERK992934LEMAITRE VENOUS THROMBECTOMY CATHETERK992940LEMAITRE BALLOON CATHETER WITH IRRIGATIONK992941LEMAITRE BILIARY CATHETER

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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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