Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K090849
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K090849
Device Name
Catheter, Percutaneous
Applicant
EV3 INC.
9600 54TH AVE NORTH
PLYMOUTH, MN 55442 US
Other 510(k) Applications for this Company
Contact
SARA BAKKAR
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
DQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2009
Decision Date
05/01/2009
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