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510(k) K010737

SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 by Medtronic Cardiac Surgical Products — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2001
Date Received
March 12, 2001
Clearance Type
Special
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

Other clearances by Medtronic Cardiac Surgical Products

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  • K012143 — 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 (October 24, 2001)
  • K000776 — MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP (February 7, 2001)
  • K994171 — MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE (April 27, 2000)
  • K000274 — EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE (February 10, 2000)

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