The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Twin-pass Otw Catheter, Model 5201.
| Device ID | K072618 |
| 510k Number | K072618 |
| Device Name: | TWIN-PASS OTW CATHETER, MODEL 5201 |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2007-11-21 |
| Summary: | summary |