The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for D-stat Handle, Model 8500-053.
| Device ID | K063871 |
| 510k Number | K063871 |
| Device Name: | D-STAT HANDLE, MODEL 8500-053 |
| Classification | Clamp, Vascular |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Alyssa Malinski |
| Correspondent | Alyssa Malinski 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 | 2006-12-29 |
| Decision Date | 2007-02-28 |
| Summary: | summary |