The following data is part of a premarket notification filed by Vasonova Inc. with the FDA for Vascular Positioning System (vps) G4 Console.
| Device ID | K123813 |
| 510k Number | K123813 |
| Device Name: | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VASONOVA INC. 155 JEFFERSON DRIVE SUITE 100 Menlo Park, CA 94025 |
| Contact | Christine Ford |
| Correspondent | Christine Ford VASONOVA INC. 155 JEFFERSON DRIVE SUITE 100 Menlo Park, CA 94025 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-11 |
| Decision Date | 2013-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902091858 | K123813 | 000 |