JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)

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 System, Models Pv20300 (jetstream G2 Catheter And Control Pod); Pvcn100 (pv Console).

Pre-market Notification Details

Device IDK083837
510k NumberK083837
Device Name:JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
ClassificationCatheter, Peripheral, Atherectomy
Applicant PATHWAY MEDICAL TECHNOLOGIES, INC. 10801 120TH AVENUE NE Kirkland,  WA  98033
ContactBrian Cleary
CorrespondentBrian Cleary
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 Received2008-12-23
Decision Date2009-01-13
Summary:summary

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