The following data is part of a premarket notification filed by Radius Medical Technologies, Inc. with the FDA for Radius Ptca Guidewire.
| Device ID | K970466 |
| 510k Number | K970466 |
| Device Name: | RADIUS PTCA GUIDEWIRE |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | RADIUS MEDICAL TECHNOLOGIES, INC. 63 GREAT RD. Maynard, MA 01754 |
| Contact | Maureen A Finlayson |
| Correspondent | Maureen A Finlayson RADIUS MEDICAL TECHNOLOGIES, INC. 63 GREAT RD. Maynard, MA 01754 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-07 |
| Decision Date | 1997-05-20 |
| Summary: | summary |