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510(k) K233702

SMARxT Tubing and Connectors by LivaNova USA, Inc. — Product Code DWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2024
Date Received
November 17, 2023
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 LivaNova USA, Inc.

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  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)

Other clearances for product code DWE

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  • 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)