JETSTREAM G2 NXT SYSTEM, MODEL PV20300

Catheter, Peripheral, Atherectomy

PATHWAY MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Pathway Medical Technologies, Inc. with the FDA for Jetstream G2 Nxt System, Model Pv20300.

Pre-market Notification Details

Device IDK091509
510k NumberK091509
Device Name:JETSTREAM G2 NXT SYSTEM, MODEL PV20300
ClassificationCatheter, Peripheral, Atherectomy
Applicant PATHWAY MEDICAL TECHNOLOGIES, INC. 10801 120TH AVENUE NE Kirkland,  WA  98033
ContactBrit Baird
CorrespondentBrit Baird
PATHWAY MEDICAL TECHNOLOGIES, INC. 10801 120TH AVENUE NE Kirkland,  WA  98033
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-22
Decision Date2009-06-19
Summary:summary

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