The following data is part of a premarket notification filed by Kaneka Corporation with the FDA for R2p Metacross Rx.
| Device ID | K163479 |
| 510k Number | K163479 |
| Device Name: | R2P Metacross RX |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | KANEKA CORPORATION 1-12-32, AKASAKA, MINATO-KU Tokyo, JP 107-6028 |
| Contact | Toshihiko Motomine |
| Correspondent | Christopher M. Sloan QUINTILES CONSULTING 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-01-11 |
| Summary: | summary |