Device Classification Name |
catheter, electrode recording, or probe, electrode recording
|
510(k) Number |
K102588 |
Device Name |
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE |
Applicant |
MEDTRONIC ABLATION FRONTIERS, LLC |
2210 FARADAY AVENUE |
SUIT 100 |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
BRENDA CLAY |
Correspondent |
MEDTRONIC ABLATION FRONTIERS, LLC |
2210 FARADAY AVENUE |
SUIT 100 |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
BRENDA CLAY |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 09/09/2010 |
Decision Date | 03/18/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|