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510(k) K180979

PureFlex Arterial Cannulae by Sorin Group Italia S.R.L. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2018
Date Received
April 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

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  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
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