The following data is part of a premarket notification filed by Vasonova Inc. with the FDA for Vascular Positioning System (vps System) Console.
| Device ID | K103260 |
| 510k Number | K103260 |
| Device Name: | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VASONOVA INC. 155 JEFFERSON DRIVE SUITE 100 Menlo Park, CA 94025 |
| Contact | Kim Tompkins |
| Correspondent | Kim Tompkins VASONOVA INC. 155 JEFFERSON DRIVE SUITE 100 Menlo Park, CA 94025 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-04 |
| Decision Date | 2011-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801902091871 | K103260 | 000 |
| 00801902078407 | K103260 | 000 |
| 40801902124300 | K103260 | 000 |
| 10801902078404 | K103260 | 000 |