Cleared Special

K024069 - ONE PIECE PEDIATRIC ARTERIAL CANNULA

K024069 is the FDA 510(k) clearance for ONE PIECE PEDIATRIC ARTERIAL CANNULA by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Special 510(k) pathway after a 29-day FDA review.

K024069 · Medtronic Vascular · Cardiovascular device
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Jan 2003
Decision
29d
Days
Class 2
Risk

K024069 is an FDA 510(k) clearance for the ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 8, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Vascular devices

Submission Details

510(k) Number K024069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2002
Decision Date January 08, 2003
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 231
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K024069.
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
K032041 · LeMaitre Vascular, Inc. · Aug 2003
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
K031518 · Medtronic Vascular · May 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
K030231 · Sorin Group Italia S.R.L. · Apr 2003
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · Ethicon, Inc. · Dec 2002
CIRCUIT TUBINGS WITH X-COATING
K023056 · Terumo Cardiovascular Systems Corp. · Nov 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · Edwards Lifesciences, LLC · Apr 2002