510(k) K221057

Viatrac 14 Plus Peripheral Dilatation Catheter by Abbott Vascular — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2022
Date Received
April 11, 2022
Clearance Type
Special
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