Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082382
Device Classification Name
More FDA Info for this Device
510(K) Number
K082382
Device Name
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
Applicant
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS, MN 55433-8003 US
Other 510(k) Applications for this Company
Contact
MARK STENOIEN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/19/2008
Decision Date
12/12/2008
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
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact