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510(k) K130333

CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR by Terumo Cardiovascular Systems Corp. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2013
Date Received
February 11, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

Other clearances by Terumo Cardiovascular Systems Corp.

  • K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenato (December 2, 2015)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K131041 — ADVANCED PERFUSION SYSTEM 1 (February 20, 2014)
  • K132451 — SARNS SOFT-FLOW AORTIC CANNULA (February 18, 2014)
  • K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA (February 3, 2014)
  • K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX (March 13, 2013)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)
  • K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS) (February 7, 2012)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)
  • K112229 — SARN CENTRIFUGAL PUMP (December 9, 2011)

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