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510(k) K012143

24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 by Medtronic Cardiac Surgical Products — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2001
Date Received
July 10, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

Other clearances by Medtronic Cardiac Surgical Products

  • K022272 — MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) (January 8, 2003)
  • K013013 — MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. (December 4, 2001)
  • K010737 — SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,788 (April 4, 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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