Device Classification Name |
Catheter, Electrode Recording, Or Probe, Electrode Recording
|
510(k) Number |
K120544 |
Device Name |
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN |
Applicant |
ST. JUDE MEDICAL |
14901 DEVEAU PL. |
MINNETONKA,
MN
55345 -2126
|
|
Applicant Contact |
MARLENE PETERSON |
Correspondent |
ST. JUDE MEDICAL |
14901 DEVEAU PL. |
MINNETONKA,
MN
55345 -2126
|
|
Correspondent Contact |
MARLENE PETERSON |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 02/23/2012 |
Decision Date | 03/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|