The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Fluent Inflation Device.
| Device ID | K152387 |
| 510k Number | K152387 |
| Device Name: | Fluent Inflation Device |
| Classification | Syringe, Balloon Inflation |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT NORTH Minneapolis, MN 55369 |
| Contact | Beka Vite |
| Correspondent | Beka Vite VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT NORTH Minneapolis, MN 55369 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-24 |
| Decision Date | 2015-12-18 |
| Summary: | summary |