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510(k) K150542

Terumo Pump Tubing by Terumo Cardiovascular Systems Corporation — Product Code DWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2015
Date Received
March 3, 2015
Clearance Type
Special
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

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  • K160206 — VirtuoSaph Plus Endoscopic Vessel Harvesting System (April 21, 2016)

Other clearances for product code DWE

  • K233702 — SMARxT Tubing and Connectors (August 8, 2024)
  • 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)
  • K993189 — CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUM (March 1, 2000)
  • K993062 — CHEST DRAINAGE TUBING (December 10, 1999)
  • K981613 — COBE SMARXT TUBING AND CONNECTORS (October 26, 1998)