CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G

Catheter, Angioplasty, Peripheral, Transluminal

TRIREME MEDICAL INC

The following data is part of a premarket notification filed by Trireme Medical Inc with the FDA for Chocolate Pta Balloon Catheter (over The Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (over The Wire) 0.18 G.

Pre-market Notification Details

Device IDK122070
510k NumberK122070
Device Name:CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 Pleasanton,  CA  94566
ContactShiva Ardakani
CorrespondentShiva Ardakani
TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 Pleasanton,  CA  94566
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-16
Decision Date2012-08-15
Summary:summary

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