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510(k) K071572

CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER by Terumo Corp. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2007
Date Received
June 8, 2007
Clearance Type
Traditional
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 Corp.

  • K100282 — TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER (February 26, 2010)
  • K092372 — HEARTRAIL III GUIDING CATHETER (September 11, 2009)
  • K091417 — SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, (May 22, 2009)
  • K090973 — TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) (May 1, 2009)
  • K073474 — CAPIOX CIRCUIT CONNECTORS (March 5, 2008)
  • K071494 — CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER (July 16, 2007)
  • K071075 — TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A (May 25, 2007)
  • K040783 — FOUNDATION (October 13, 2004)
  • K040210 — CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR (March 3, 2004)
  • K033681 — GLIDESHEATH (December 11, 2003)

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