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FDA 510(k)

LEMILLS VALVULOTOME

K-Number: K132047 · 2013-11-05

ApplicantLeMaitre Vascular, Inc.
Decision Date2013-11-05
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMILLS VALVULOTOME is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2013-11-05 under 510(k) number K132047. 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 LEMILLS VALVULOTOME?

LEMILLS VALVULOTOME is a medical device that received FDA 510(k) clearance on 2013-11-05. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K132047.

When did LEMILLS VALVULOTOME receive FDA 510(k) clearance?

LEMILLS VALVULOTOME received FDA 510(k) clearance on 2013-11-05, under 510(k) number K132047.

Who is the listed applicant for LEMILLS VALVULOTOME?

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

What is the FDA product code for LEMILLS VALVULOTOME?

The FDA product code for LEMILLS VALVULOTOME is MGZ.

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Other records listing LeMaitre Vascular, 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.

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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 VascularK132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.K111884OVER-THE-WIRE EXPANDABLE 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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