Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080179
Device Classification Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
More FDA Info for this Device
510(K) Number
K080179
Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA, MN 55345-2126 US
Other 510(k) Applications for this Company
Contact
ANDREA HUDACK
Other 510(k) Applications for this Contact
Regulation Number
870.1220
More FDA Info for this Regulation Number
Classification Product Code
DRF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/24/2008
Decision Date
01/07/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact