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510(k) K993189

CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING by Terumo Corp. — Product Code DWE

K993189 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING". The FDA issued a decision of Substantially Equivalent on March 1, 2000. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. Terumo Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2000
Date Received
September 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pump, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4390
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)
  • K071572 — CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER (July 23, 2007)
  • 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)

Other clearances for product code DWE

  • K233702 — SMARxT Tubing and Connectors (August 8, 2024)
  • K150542 — Terumo Pump Tubing (May 1, 2015)
  • K142607 — AngioVac Circuit (December 11, 2014)
  • K092486 — VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT (August 28, 2009)
  • K080592 — HLM TUBING SET WITH BIOLINE COATING (September 11, 2008)
  • K053025 — JOSTRA HLM TUBING SET (November 10, 2005)
  • K022857 — PUMP TUBING WITH X-COATING (September 19, 2002)
  • K013578 — PUMP TUBING (January 22, 2002)
  • K993062 — CHEST DRAINAGE TUBING (December 10, 1999)
  • K981613 — COBE SMARXT TUBING AND CONNECTORS (October 26, 1998)

FDA data resources