VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

Catheter, Ultrasound, Intravascular

VASONOVA INC.

The following data is part of a premarket notification filed by Vasonova Inc. with the FDA for Vascular Positioning System (vps System) Console.

Pre-market Notification Details

Device IDK103260
510k NumberK103260
Device Name:VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
ClassificationCatheter, Ultrasound, Intravascular
Applicant VASONOVA INC. 155 JEFFERSON DRIVE SUITE 100 Menlo Park,  CA  94025
ContactKim Tompkins
CorrespondentKim Tompkins
VASONOVA INC. 155 JEFFERSON DRIVE SUITE 100 Menlo Park,  CA  94025
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-04
Decision Date2011-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00801902091871 K103260 000
00801902078407 K103260 000
40801902124300 K103260 000
10801902078404 K103260 000

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