Protek Solo 24 Fr Venous Cannula Set— 510(k) K162214

Name: FDA 510(k) clearance K162214
Creator: U.S. Food and Drug Administration
Published: 2016-11-30

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K162214 for Protek Solo 24 Fr Venous Cannula Set, Substantially Equivalent on 2016-11-30. Applicant: Cardiacassist, Inc.. Device class: 2.

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2016-08-08
Decision date: 2016-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWF

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K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
K250937 — Venous Return Cannulae2026-03-11
K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23
K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
K253671 — Dual Stage Venous Cannulae2026-01-30

More clearances from Cardiacassist, Inc.

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K233736 — LifeSPARC System2024-01-19
K232480 — ProtekDuo Veno-Venous Cannula Sets2023-10-06
K232132 — LifeSPARC System2023-08-03
K211830 — LifeSPARC System2022-11-15
K202751 — TandemHeart Pump and Escort Controller2021-03-26

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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 →

Recalls naming K162214

K-number listed on FDA's recall record

Z-1106-2020 — TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.Class II·Terminated·Cardiac Assist, Inc·20191119

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162214.

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