Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K070502 |
Device Name |
RADIUS SNARE |
Applicant |
RADIUS MEDICAL TECHNOLOGIES, INC. |
15 CRAIG RD. |
ACTON,
MA
01720
|
|
Applicant Contact |
RICHARD DEMELLO |
Correspondent |
RADIUS MEDICAL TECHNOLOGIES, INC. |
15 CRAIG RD. |
ACTON,
MA
01720
|
|
Correspondent Contact |
RICHARD DEMELLO |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/21/2007 |
Decision Date | 10/04/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|