PolyCatch Retrieval Device

Snare, Flexible

Medi-Globe Corporation

The following data is part of a premarket notification filed by Medi-globe Corporation with the FDA for Polycatch Retrieval Device.

Pre-market Notification Details

Device IDK142258
510k NumberK142258
Device Name:PolyCatch Retrieval Device
ClassificationSnare, Flexible
Applicant Medi-Globe Corporation 110 West Orion Street Tempe,  AZ  85283
ContactScott Karler
CorrespondentScott Karler
Medi-Globe Corporation 110 West Orion Street Tempe,  AZ  85283
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-14
Decision Date2014-09-30
Summary:summary

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