The following data is part of a premarket notification filed by Paieon, Inc. with the FDA for C-thv System.
| Device ID | K113594 |
| 510k Number | K113594 |
| Device Name: | C-THV SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | PAIEON, INC. 22 HAMELACHA ST., P.O.B. 11355 Rosh Haayin, IL 48901 |
| Contact | Erez Ben-zvi |
| Correspondent | Erez Ben-zvi PAIEON, INC. 22 HAMELACHA ST., P.O.B. 11355 Rosh Haayin, IL 48901 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2012-03-02 |
| Summary: | summary |