The following data is part of a premarket notification filed by Vasonova Inc. with the FDA for Flowpicc Console.
| Device ID | K081626 |
| 510k Number | K081626 |
| Device Name: | FLOWPICC CONSOLE |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VASONOVA INC. 1368 BORDEAUX DR., SUITE 100 Sunnyvale, CA 94089 |
| Contact | Sorin Grunwald |
| Correspondent | Sorin Grunwald VASONOVA INC. 1368 BORDEAUX DR., SUITE 100 Sunnyvale, CA 94089 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-10 |
| Decision Date | 2008-10-15 |
| Summary: | summary |