510(k) K926252

CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY by Endosonics Corp. — Product Code IYO

K926252 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY". The FDA issued a decision of Substantially Equivalent on October 25, 1993. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Endosonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1993
Date Received
December 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type