The following data is part of a premarket notification filed by Terumo Medical Products (hangzhou) Co., Ltd. with the FDA for Radifocus Torque Device.
| Device ID | K220934 |
| 510k Number | K220934 |
| Device Name: | RADIFOCUS Torque Device |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5, Economic & Technological Development Zone Hangzhou, CN 310018 |
| Contact | Qing Liu |
| Correspondent | Qing Liu Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset, NJ 08873 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 56927675513484 | K220934 | 000 |