510(k) K953522

USCI IDEAL PTCA KIT by Ryder Intl. Corp. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1996
Date Received
July 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type