The following data is part of a premarket notification filed by Radius Medical Technologies, Inc. with the FDA for Radius Snare.
| Device ID | K070502 |
| 510k Number | K070502 |
| Device Name: | RADIUS SNARE |
| Classification | Catheter, Percutaneous |
| Applicant | RADIUS MEDICAL TECHNOLOGIES, INC. 15 CRAIG RD. Acton, MA 01720 |
| Contact | Richard Demello |
| Correspondent | Richard Demello RADIUS MEDICAL TECHNOLOGIES, INC. 15 CRAIG RD. Acton, MA 01720 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-21 |
| Decision Date | 2007-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841156101491 | K070502 | 000 |
| 30841156101484 | K070502 | 000 |