Cleared Traditional

K170488 - Peak Left Ventricular Vent Cannula, 20 Fr. (FDA 510(k) Clearance)

Also includes:
Peak Left Ventricular Vent Cannula, 18 Fr Peak Left Ventricular Vent Cannula, 16 Fr

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170488 · Surge Cardiovascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
174d
Days
Class 2
Risk

K170488 is an FDA 510(k) clearance for the Peak Left Ventricular Vent Cannula, 20 Fr.. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Surge Cardiovascular (Grand Rapids, US). The FDA issued a Cleared decision on August 10, 2017 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Surge Cardiovascular devices

Submission Details

510(k) Number K170488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2017
Decision Date August 10, 2017
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 400
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