EZE SIT Valvulotome— 510(k) K190267

Substantially Equivalent

Lemaitre Vascular

FDA 510(k) clearance K190267 for EZE SIT Valvulotome, Substantially Equivalent on 2019-10-30. Applicant: Lemaitre Vascular.

Clearance details

Applicant: Lemaitre Vascular
Product code: Code MGZ
Advisory panel: Cardiovascular
Date received: 2019-02-08
Decision date: 2019-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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