D-STAT RADIAL HEMOSTATIC BAND

Dressing, Wound, Drug

VASCULAR SOLUTIONS, INC.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for D-stat Radial Hemostatic Band.

Pre-market Notification Details

Device IDK050133
510k NumberK050133
Device Name:D-STAT RADIAL HEMOSTATIC BAND
ClassificationDressing, Wound, Drug
Applicant VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
ContactLinda Busklein
CorrespondentLinda Busklein
VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2005-01-21
Decision Date2005-02-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.