Spartan SC 069

Catheter, Percutaneous

Spartan Micro, Inc.

The following data is part of a premarket notification filed by Spartan Micro, Inc. with the FDA for Spartan Sc 069.

Pre-market Notification Details

Device IDK220716
510k NumberK220716
Device Name:Spartan SC 069
ClassificationCatheter, Percutaneous
Applicant Spartan Micro, Inc. Costa Mesa,  CA  92626
ContactGary Avedovech
CorrespondentGary Avedovech
Spartan Micro 3184 Airway Ave, Suite C Costa Mesa,  CA  92626
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-11
Decision Date2022-05-05

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