The following data is part of a premarket notification filed by Radius Medical Technologies, Inc. with the FDA for Modification To Radius Snare.
Device ID | K071457 |
510k Number | K071457 |
Device Name: | MODIFICATION TO RADIUS SNARE |
Classification | Device, Percutaneous Retrieval |
Applicant | RADIUS MEDICAL TECHNOLOGIES, INC. 15 CRAIG ROAD Acton, MA 01720 |
Contact | Maureen Finlayson |
Correspondent | Maureen Finlayson RADIUS MEDICAL TECHNOLOGIES, INC. 15 CRAIG ROAD Acton, MA 01720 |
Product Code | MMX |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-25 |
Decision Date | 2007-09-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30841156101583 | K071457 | 000 |
30841156101569 | K071457 | 000 |
30841156101545 | K071457 | 000 |
30841156101521 | K071457 | 000 |
30841156101507 | K071457 | 000 |