The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Venture 038 Catheter.
| Device ID | K171335 |
| 510k Number | K171335 |
| Device Name: | Venture 038 Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Vascular Solutions, Inc. 6464 Sycamore Court N Minneapolis, MN 55369 |
| Contact | Beka Vite |
| Correspondent | Beka Vite Vascular Solutions, Inc. 6464 Sycamore Court N 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 | 2017-05-08 |
| Decision Date | 2017-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20658230 | K171335 | 000 |
| 30841156100838 | K171335 | 000 |
| 30841156100821 | K171335 | 000 |