Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K063204
Device Classification Name
Temporary Carotid Catheter For Embolic Capture
More FDA Info for this Device
510(K) Number
K063204
Device Name
Temporary Carotid Catheter For Embolic Capture
Applicant
EV3 INC
9600 54TH AVENUE NORTH
PLYMOUTH, MN 55442-2920 US
Other 510(k) Applications for this Company
Contact
David Worrell
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
NTE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/23/2006
Decision Date
11/14/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact