510(k) K914880

DUAL BALLOON EMBOLECTOMY CATHETER by Ideal Medical, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1992
Date Received
October 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type