VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE

Powered Laser Surgical Instrument

VASCULAR SOLUTIONS, INC.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions Vari-lase Endovenous Laser Console.

Pre-market Notification Details

Device IDK033237
510k NumberK033237
Device Name:VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
ClassificationPowered Laser Surgical Instrument
Applicant VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
ContactDeborah L Jensen
CorrespondentDeborah L Jensen
VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-06
Decision Date2003-11-20
Summary:summary

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