The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Horizon Xvu (ffr).
| Device ID | K123792 |
| 510k Number | K123792 |
| Device Name: | HORIZON XVU (FFR) |
| Classification | Wire, Guide, Catheter |
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 |
| Contact | Ifat Shwarts |
| Correspondent | Ifat Shwarts MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-08-30 |
| Summary: | summary |