Cleared Traditional

K143083 - Bio-Medicus Pediatric Cannula and Intro...

K143083 is the FDA 510(k) clearance for Bio-Medicus Pediatric Cannula and Intro... by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K143083 · Medtronic, Inc. · Cardiovascular device
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Mar 2015
Decision
149d
Days
Class 2
Risk

K143083 is an FDA 510(k) clearance for the Bio-Medicus Pediatric Cannula and Introducers. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 25, 2015 after a review of 149 days - within the typical 510(k) review window.

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, Inc. devices

Submission Details

510(k) Number K143083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2014
Decision Date March 25, 2015
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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 148
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K143083.
Medtronic Bio-Medicus Adult Cannula Kit
K153598 · Medtronic, Inc. · Jan 2016
Uncoated Tubing and Connector Components
K151523 · Medtronic, Inc. · Jul 2015
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
K150567 · Medtronic, Inc. · Apr 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