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510(k) K213540

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set by Qura S.R.L — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2022
Date Received
November 8, 2021
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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