The following data is part of a premarket notification filed by Radius Medical Technologies, Inc. with the FDA for Radius Micro Snare.
| Device ID | K022201 |
| 510k Number | K022201 |
| Device Name: | RADIUS MICRO SNARE |
| Classification | Device, Percutaneous Retrieval |
| 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 | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2003-02-03 |
| Summary: | summary |