The following data is part of a premarket notification filed by Kaneka Corporation with the FDA for Rx Takeru Balloon Dilatation Catheter.
| Device ID | K163372 |
| 510k Number | K163372 |
| Device Name: | RX Takeru Balloon Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| 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 | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-01 |
| Decision Date | 2017-04-07 |
| Summary: | summary |