The following data is part of a premarket notification filed by Vasonova Inc. with the FDA for Flowpicc Catheter.
| Device ID | K082481 |
| 510k Number | K082481 |
| Device Name: | FLOWPICC CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VASONOVA INC. 1368 BORDEAUX DR., SUITE 100 Sunnyvale, CA 94089 |
| Contact | Tina Cheng |
| Correspondent | Tina Cheng 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 | 2008-08-28 |
| Decision Date | 2008-12-17 |
| Summary: | summary |