The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Twin-pass .023 Dual Access Catheter, Model 5230.
| Device ID | K062877 |
| 510k Number | K062877 |
| Device Name: | TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-26 |
| Decision Date | 2007-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20652300 | K062877 | 000 |