The following data is part of a premarket notification filed by Radius Medical Technologies, Inc. with the FDA for Radius Snare.
Device ID | K021441 |
510k Number | K021441 |
Device Name: | RADIUS SNARE |
Classification | Device, Percutaneous Retrieval |
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 | MMX |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-06 |
Decision Date | 2002-06-14 |
Summary: | summary |