The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Glidewire For Coronary Use With Platinum (or Gold) Coil.
| Device ID | K961445 |
| 510k Number | K961445 |
| Device Name: | RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL |
| Classification | Wire, Guide, Catheter |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Keith M Smith |
| Correspondent | Keith M Smith TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-16 |
| Decision Date | 1996-07-09 |
| Summary: | summary |