The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Gopher Gold Catheter, Model 5620.
| Device ID | K091345 |
| 510k Number | K091345 |
| Device Name: | GOPHER GOLD CATHETER, MODEL 5620 |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Loucinda Bjorklund |
| Correspondent | Loucinda Bjorklund VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-06 |
| Decision Date | 2009-06-12 |
| Summary: | summary |