Cleared Traditional

K140569 - ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)

K140569 is the FDA 510(k) clearance for ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K140569 · Maquet Cardiopulmonary, AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
258d
Days
Class 2
Risk

K140569 is an FDA 510(k) clearance for the ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE). Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Rastatt De-Bw, DE). The FDA issued a Cleared decision on November 19, 2014 after a review of 258 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K140569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2014
Decision Date November 19, 2014
Days to Decision 258 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 125d · This submission: 258d
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 202
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K140569.
Bio-Medicus Pediatric Cannula and Introducers
K143083 · Medtronic, Inc. · Mar 2015
EOPA 3D Arterial Cannula
K150422 · Medtronic, Inc. · Mar 2015
DLP Vein Graft Cannula
K143107 · Medtronic, Inc. · Jan 2015
Bio-Medicus Adult Cannulae and Introducer
K142673 · Medtronic, Inc. · Nov 2014
AngioVac Cannula
K142593 · AngioDynamics, Inc. · Nov 2014
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
K141951 · Medtronic, Inc. · Aug 2014