Cleared Special

K031827 - ULTRAFLEX VENOUS CANNULA

K031827 is an FDA 510(k) clearance for ULTRAFLEX VENOUS CANNULA, manufactured by Medtronic Perfusion Systems. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 19-day FDA review.

K031827 · Medtronic Perfusion Systems · Cardiovascular device
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Jul 2003
Decision
19d
Days
Class 2
Risk

K031827 is an FDA 510(k) clearance for the ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on July 2, 2003 after a review of 19 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 Perfusion Systems devices

FDA 510(k) Submission Details - K031827

510(k) Number K031827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2003
Decision Date July 02, 2003
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 269
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K031827.
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
K033264 · Medtronic Perfusion Systems · Oct 2003
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
K032041 · LeMaitre Vascular, Inc. · Aug 2003
MC2X MULTI-STAGE VENOUS CANNULA
K031776 · Medtronic Perfusion Systems · Jul 2003
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
K031518 · Medtronic Vascular · May 2003
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
K031037 · Medtronic Perfusion Systems · May 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
K030231 · Sorin Group Italia S.R.L. · Apr 2003