The following data is part of a premarket notification filed by Radius Medical Technologies, Inc. with the FDA for Radius Next Generation Guidewire.
| Device ID | K011759 |
| 510k Number | K011759 |
| Device Name: | RADIUS NEXT GENERATION GUIDEWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | RADIUS MEDICAL TECHNOLOGIES, INC. 63 GREAT RD. Maynard, MA 01754 |
| Contact | Maureen Finlayson |
| Correspondent | Maureen Finlayson RADIUS MEDICAL TECHNOLOGIES, INC. 63 GREAT RD. Maynard, MA 01754 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-06 |
| Decision Date | 2001-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405053996 | K011759 | 000 |
| 10653405053903 | K011759 | 000 |
| 10653405053910 | K011759 | 000 |
| 10653405053927 | K011759 | 000 |
| 10653405053934 | K011759 | 000 |
| 10653405053941 | K011759 | 000 |
| 10653405053958 | K011759 | 000 |
| 10653405053965 | K011759 | 000 |
| 10653405053972 | K011759 | 000 |
| 10653405053989 | K011759 | 000 |
| 10653405053897 | K011759 | 000 |