510(k) K133843

SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER by Cordis Corporation — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2014
Date Received
December 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type