XenoSure Biologic Patch— 510(k) K190882

Substantially Equivalent

Lemaitre Vascular

FDA 510(k) clearance K190882 for XenoSure Biologic Patch, Substantially Equivalent on 2020-02-13. Applicant: Lemaitre Vascular. Device class: 2.

Clearance details

Applicant: Lemaitre Vascular
Product code: Code PSQ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2019-04-04
Decision date: 2020-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.