Home / 510(k) Clearances / K153213

510(k) K153213

Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir by Terumo Cardiovascular Systems Corporation — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2015
Date Received
November 5, 2015
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 Corporation

  • K234065 — CDI OneView Monitoring System (April 25, 2024)
  • K221895 — Terumo Advanced Perfusion System 1 (April 18, 2023)
  • K200091 — Capiox iCP Centrifugal Pump (November 18, 2021)
  • K182110 — CDI Blood Parameter Monitoring System 550 (November 2, 2018)
  • K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox N (June 22, 2018)
  • K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox (March 29, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roll (November 17, 2016)
  • K160206 — VirtuoSaph Plus Endoscopic Vessel Harvesting System (April 21, 2016)

Other clearances for product code DTZ

  • K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Bl (March 12, 2026)
  • K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (December 12, 2025)
  • K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (November 24, 2025)
  • K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator V (September 12, 2024)
  • K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac (July 10, 2024)
  • K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity (June 12, 2024)
  • K231652 — D100 KIDS; D101 KIDS (November 16, 2023)
  • K231773 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quant (November 8, 2023)
  • K231414 — CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (November 1, 2023)
  • K230640 — Affinity Fusion™ Oxygenator System (April 6, 2023)