Cleared Traditional

K022272 - MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) (FDA 510(k) Clearance)

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

K022272 · Medtronic Cardiac Surgical Products · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
177d
Days
Class 2
Risk

K022272 is an FDA 510(k) clearance for the MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES). Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic Cardiac Surgical Products (Grad Rapids, US). The FDA issued a Cleared decision on January 8, 2003 after a review of 177 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 Medtronic Cardiac Surgical Products devices

Submission Details

510(k) Number K022272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2002
Decision Date January 08, 2003
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
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
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K022272.
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
K260195 · Medtronic, Inc. · Apr 2026
Venous Return Cannulae
K250937 · LivaNova USA, Inc. · Mar 2026
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
K260043 · Smart Reactors · Feb 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · Medtronic, Inc. · Feb 2026
Dual Stage Venous Cannulae
K253671 · Sorin Group Italia S.R.L. · Jan 2026
Clearview Intracoronary Shunts
K253998 · Medtronic, Inc. · Jan 2026