MiniGuard Arterial Safety Valve— 510(k) K182442

Substantially Equivalent

Quest Medical, Inc.

FDA 510(k) clearance K182442 for MiniGuard Arterial Safety Valve, Substantially Equivalent on 2018-11-06. Applicant: Quest Medical, Inc.. Device class: 2.

Clearance details

Applicant
Quest Medical, Inc.
Product code
Code MJJ
Device class
Class 2
Regulation
21 CFR 870.4400
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Allen, TX, US
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