MICRO THERAPEUTICS INFUSION CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

MICRO THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Micro Therapeutics Infusion Catheter.

Pre-market Notification Details

Device IDK940634
510k NumberK940634
Device Name:MICRO THERAPEUTICS INFUSION CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MICRO THERAPEUTICS, INC. 27412-B LAGUNA HILLS DR. Aliso Viejo,  CA  92656
ContactLinda D'abate
CorrespondentLinda D'abate
MICRO THERAPEUTICS, INC. 27412-B LAGUNA HILLS DR. Aliso Viejo,  CA  92656
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-14
Decision Date1994-10-14

NIH GUDID Devices

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