MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT

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 Modification To Vascular Solutions Vari-lase Endovenous Laser Procedure Kit.

Pre-market Notification Details

Device IDK032805
510k NumberK032805
Device Name:MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
ClassificationPowered Laser Surgical Instrument
Applicant VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
ContactDeborah Jensen
CorrespondentDeborah Jensen
VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-09
Decision Date2003-10-01
Summary:summary

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