The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Optitorque.
| Device ID | K992051 |
| 510k Number | K992051 |
| Device Name: | RADIFOCUS OPTITORQUE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-18 |
| Decision Date | 1999-08-10 |
| Summary: | summary |