GUIDELINER V2 CATHETER

Catheter, Percutaneous

VASCULAR SOLUTIONS, INC.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Guideliner V2 Catheter.

Pre-market Notification Details

Device IDK112082
510k NumberK112082
Device Name:GUIDELINER V2 CATHETER
ClassificationCatheter, Percutaneous
Applicant VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis,  MN  55369
ContactMatt Nienstedt
CorrespondentMatt Nienstedt
VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis,  MN  55369
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-21
Decision Date2011-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M20655760 K112082 000

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