Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K052509
Device Classification Name
Device, Neurovascular Embolization
More FDA Info for this Device
510(K) Number
K052509
Device Name
Device, Neurovascular Embolization
Applicant
SCION CARDIO-VASCULAR, INC.
14256 SW 119TH AVE.
MIAMI, FL 33186 US
Other 510(k) Applications for this Company
Contact
SUZANA OTANO-LATA
Other 510(k) Applications for this Contact
Regulation Number
882.5950
More FDA Info for this Regulation Number
Classification Product Code
HCG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2005
Decision Date
12/11/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact