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 |