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 Vari-lase Endovenous Laser Procedure Kit.

Pre-market Notification Details

Device IDK051287
510k NumberK051287
Device Name:VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
ClassificationPowered Laser Surgical Instrument
Applicant VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
ContactLinda Busklein
CorrespondentLinda Busklein
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 Received2005-05-18
Decision Date2005-07-29
Summary:summary

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