The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Guide Wire M.
| Device ID | K923607 |
| 510k Number | K923607 |
| Device Name: | RADIFOCUS GUIDE WIRE M |
| Classification | Catheter, Urological |
| Applicant | TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1992-10-02 |