Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082304
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K082304
Device Name
Wire, Guide, Catheter
Applicant
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA, MN 55345-2126 US
Other 510(k) Applications for this Company
Contact
JEFF STURM
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2008
Decision Date
08/27/2008
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact