Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K121776 |
Device Name |
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE |
Applicant |
Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Applicant Contact |
JOAN BARTLE |
Correspondent |
Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent Contact |
JOAN BARTLE |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 06/18/2012 |
Decision Date | 08/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|