The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Minnie Support Catheter.
| Device ID | K082337 |
| 510k Number | K082337 |
| Device Name: | MINNIE SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Charmaine Sutton |
| Correspondent | Charmaine Sutton VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-14 |
| Decision Date | 2009-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20657130 | K082337 | 000 |
| M20657000 | K082337 | 000 |
| 30841156100814 | K082337 | 000 |
| 30841156100807 | K082337 | 000 |
| 30841156100791 | K082337 | 000 |
| 30841156100784 | K082337 | 000 |
| 30841156100777 | K082337 | 000 |
| 30841156100760 | K082337 | 000 |
| 30841156100753 | K082337 | 000 |
| M20657010 | K082337 | 000 |
| M20657020 | K082337 | 000 |
| M20657030 | K082337 | 000 |
| M20657120 | K082337 | 000 |
| M20657110 | K082337 | 000 |
| M20657100 | K082337 | 000 |
| M20657080 | K082337 | 000 |
| M20657070 | K082337 | 000 |
| M20657060 | K082337 | 000 |
| M20657050 | K082337 | 000 |
| M20657040 | K082337 | 000 |
| 30841156100746 | K082337 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MINNIE SUPPORT CATHETER 77447309 3617271 Dead/Cancelled |
Vascular Solutions, Inc. 2008-04-14 |