The following data is part of a premarket notification filed by Kaneka Corporation with the FDA for Crosperio Rx Pta Balloon Dilatation Catheter.
| Device ID | K152887 |
| 510k Number | K152887 |
| Device Name: | Crosperio RX PTA Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Kaneka Corporation 1-12-32, Akasaka, Minato-ku Tokyo, JP 107-6025 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-01-22 |
| Summary: | summary |