VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE

Dressing, Wound, Drug

VASCULAR SOLUTIONS, INC.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions D-stat 2 Dry Hemostatic Bandage.

Pre-market Notification Details

Device IDK033709
510k NumberK033709
Device Name:VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
ClassificationDressing, Wound, Drug
Applicant VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
ContactGregory W Sachs
CorrespondentGregory W Sachs
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 Received2003-11-26
Decision Date2003-12-18
Summary:summary

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