The following data is part of a premarket notification filed by Vasonova Inc. with the FDA for Vps Catheter.
| Device ID | K091924 |
| 510k Number | K091924 |
| Device Name: | VPS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VASONOVA INC. 1368 BORDEAUX DR., SUITE 100 Sunnyvale, CA 94089 |
| Contact | Kim Tompkins |
| Correspondent | Kim Tompkins VASONOVA INC. 1368 BORDEAUX DR., SUITE 100 Sunnyvale, CA 94089 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-11-18 |
| Summary: | summary |