The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions D-stat Dry Hemostatic Bandage, The D-stat Radial Hemostatic Band And The D-stat 2 Dry Hemostatic.
Device ID | K040118 |
510k Number | K040118 |
Device Name: | VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC |
Classification | Dressing, Wound, Drug |
Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
Contact | Gregory W Sachs |
Correspondent | Gregory W Sachs VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2004-01-20 |
Decision Date | 2004-02-12 |
Summary: | summary |