Peak Left Ventricular Vent Cannula, 20 Fr. +2 more— 510(k) K170488

Name: FDA 510(k) clearance K170488
Creator: U.S. Food and Drug Administration
Published: 2017-08-10

Substantially Equivalent

Surge Cardiovascular

FDA 510(k) clearance K170488 for Peak Left Ventricular Vent Cannula, 20 Fr. +2 more, Substantially Equivalent on 2017-08-10. Applicant: Surge Cardiovascular. Device class: 2.

Clearance details

Device name as filed: Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr
Applicant: Surge Cardiovascular
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2017-02-17
Decision date: 2017-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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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

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 →

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