510(k) K030966

CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER by Boston Scientific Corp — Product Code NAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2003
Date Received
March 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class
Class II
Regulation Number
870.3300
Review Panel
OB
Submission Type