VasoGuard (V10, V8, V6, V4, V2)— 510(k) K233976

Name: FDA 510(k) clearance K233976
Creator: U.S. Food and Drug Administration
Published: 2024-07-19

Substantially Equivalent

Corvascular Diagnostics, LLC

FDA 510(k) clearance K233976 for VasoGuard (V10, V8, V6, V4, V2), Substantially Equivalent on 2024-07-19. Applicant: Corvascular Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Corvascular Diagnostics, LLC
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 2023-12-15
Decision date: 2024-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayzata, MN, US

Download summary PDF View on FDA.gov ↗

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