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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 the device name listed in this FDA 510(k) record. The listed applicant is Lemaitre Vascular. It received FDA 510(k) clearance on 2019-10-30 under 510(k) 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. The listed applicant is Lemaitre Vascular. The 510(k) number is K190267.

When did EZE SIT Valvulotome receive FDA 510(k) clearance?

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

Who is the listed applicant for EZE SIT Valvulotome?

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

What is the FDA product code for EZE SIT Valvulotome?

The FDA product code for EZE SIT Valvulotome is MGZ.

Other records listing Lemaitre Vascular 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.

PMA N16837Tissue graft of 6mm and greaterK212894PhasTIPPK190882XenoSure Biologic PatchK183513XenoSure Dura Biologic PatchK182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrPMA P020049Tissue graft of 6mm and greater

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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.

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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