The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Qxt Extraction Catheter.
| Device ID | K071727 |
| 510k Number | K071727 |
| Device Name: | QXT EXTRACTION CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Julie Tapper |
| Correspondent | Julie Tapper VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-25 |
| Decision Date | 2007-09-28 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QXT EXTRACTION CATHETER 77147566 3450489 Dead/Cancelled |
Vascular Solutions, Inc. 2007-04-03 |