The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Corporation with the FDA for Finecross M3.
| Device ID | K203521 |
| 510k Number | K203521 |
| Device Name: | FineCross M3 |
| Classification | Catheter, Percutaneous |
| Applicant | Ashitaka Factory Of Terumo Corporation 150 Maimaigi-cho Fujinomiya, JP 418-0015 |
| Contact | Vaibhav Sivaramakrishan |
| Correspondent | Vaibhav Sivaramakrishan Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset, NJ 08873 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-01 |
| Decision Date | 2021-03-03 |