The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions D-stat Clamp Hemostatic Clamp.
| Device ID | K040730 |
| 510k Number | K040730 |
| Device Name: | VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP |
| Classification | Clamp, Vascular |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Deborah L Neymark |
| Correspondent | Deborah L Neymark VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-22 |
| Decision Date | 2004-06-18 |
| Summary: | summary |