The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Thrombix 3x3 Hemostatic Pad.
Device ID | K053054 |
510k Number | K053054 |
Device Name: | THROMBIX 3X3 HEMOSTATIC PAD |
Classification | Dressing, Wound, Drug |
Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
Contact | Linda Busklein |
Correspondent | Linda Busklein 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 | 2005-10-31 |
Decision Date | 2005-11-23 |
Summary: | summary |