510(k) K961716

VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE by Ideas For Medicine, Inc. — Product Code DXE

K961716 is an FDA 510(k) premarket notification submitted by Ideas For Medicine, Inc. for the device "VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE". The FDA issued a decision of Substantially Equivalent on September 19, 1996. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Ideas For Medicine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1996
Date Received
May 2, 1996
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