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510(k) K221832

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter by Cordis US Corp — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2022
Date Received
June 23, 2022
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

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