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510(k) K233702

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

K233702 is an FDA 510(k) premarket notification submitted by LivaNova USA, Inc. for the device "SMARxT Tubing and Connectors". The FDA issued a decision of Substantially Equivalent on August 8, 2024. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. LivaNova USA, Inc. has at least 2 other 510(k) clearances on record.

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.

  • K250937 — Venous Return Cannulae (March 11, 2026)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)

Other clearances for product code DWE

  • 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)
  • 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)

FDA data resources