Cleared Traditional

K143083 - Bio-Medicus Pediatric Cannula and Introducers

K143083 is an FDA 510(k) clearance for Bio-Medicus Pediatric Cannula and Intro..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K143083

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.

DWF Device Classification - Class 2, Special Controls

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 302
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K143083.
Uncoated Tubing and Connector Components
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MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
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EOPA 3D Arterial Cannula
K150422 · Medtronic, Inc. · Mar 2015
DLP Vein Graft Cannula
K143107 · Medtronic, Inc. · Jan 2015
ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
K140569 · Maquet Cardiopulmonary, AG · Nov 2014