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 |