MiniGuard Arterial Safety Valve

Cpb Check Valve, Retrograde Flow, In-line

Quest Medical, Inc.

The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Miniguard Arterial Safety Valve.

Pre-market Notification Details

Device IDK182442
510k NumberK182442
Device Name:MiniGuard Arterial Safety Valve
ClassificationCpb Check Valve, Retrograde Flow, In-line
Applicant Quest Medical, Inc. One Allentown Parkway Allen,  TX  75002
ContactTosan Onosode
CorrespondentTosan Onosode
Quest Medical, Inc. One Allentown Parkway Allen,  TX  75002
Product CodeMJJ  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-07
Decision Date2018-11-06
Summary:summary

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