The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus(r) (catheter) Guide Wire.
| Device ID | K924202 |
| 510k Number | K924202 |
| Device Name: | RADIFOCUS(R) (CATHETER) GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Contact | George S Momoda |
| Correspondent | George S Momoda TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1992-11-23 |