The following data is part of a premarket notification filed by Radius Medical Technologies, Inc. with the FDA for Radius Cougar Wire.
| Device ID | K011287 |
| 510k Number | K011287 |
| Device Name: | RADIUS COUGAR WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | RADIUS MEDICAL TECHNOLOGIES, INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro RADIUS MEDICAL TECHNOLOGIES, INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-27 |
| Decision Date | 2001-05-25 |