Device Classification Name |
Catheter, Electrode Recording, Or Probe, Electrode Recording
|
510(k) Number |
K122461 |
Device Name |
RHYTHMIA MAPPING CATHETER |
Applicant |
RHYTHMIA MEDICAL, INC |
111 SOUTH BEDFORD ST SUITE 205 |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
LEON AMARIGLIO |
Correspondent |
RHYTHMIA MEDICAL, INC |
111 SOUTH BEDFORD ST SUITE 205 |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
LEON AMARIGLIO |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 08/13/2012 |
Decision Date | 04/18/2013 |
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
|
|
|