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FDA 510(k)

EZE SIT Valvulotome

K-Number: K190267 · 2019-10-30

ApplicantLemaitre Vascular
Decision Date2019-10-30
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EZE SIT Valvulotome is a medical device manufactured by Lemaitre Vascular. It received FDA 510(k) clearance on 2019-10-30 under approval number K190267. 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 EZE SIT Valvulotome?

EZE SIT Valvulotome is a medical device that received FDA 510(k) clearance on 2019-10-30. It is manufactured by Lemaitre Vascular. The 510(k) number is K190267.

When was EZE SIT Valvulotome approved by the FDA?

EZE SIT Valvulotome received FDA 510(k) clearance on 2019-10-30, under approval number K190267.

What company makes EZE SIT Valvulotome?

EZE SIT Valvulotome is manufactured by Lemaitre Vascular.

What is the FDA product code for EZE SIT Valvulotome?

The FDA product code for EZE SIT Valvulotome is MGZ.

Other Devices by Lemaitre Vascular

K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr K190882XenoSure Biologic Patch

Related Devices (Code: MGZ)

K221902LimFlow VectorLimFlow, Inc. K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc. K260188LimFlow VectorLimFlow, 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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