SMARxT Tubing and Connectors— 510(k) K233702

Name: FDA 510(k) clearance K233702
Creator: U.S. Food and Drug Administration
Published: 2024-08-08

Substantially Equivalent

LivaNova USA, Inc.

FDA 510(k) clearance K233702 for SMARxT Tubing and Connectors, Substantially Equivalent on 2024-08-08. Applicant: LivaNova USA, Inc.. Device class: 2.

Clearance details

Applicant: LivaNova USA, Inc.
Product code: Code DWE
Device class: Class 2
Regulation: 21 CFR 870.4390
Advisory panel: Cardiovascular
Date received: 2023-11-17
Decision date: 2024-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

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K080592 — HLM TUBING SET WITH BIOLINE COATING2008-09-11
K053025 — JOSTRA HLM TUBING SET2005-11-10

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Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.