Cleared Special

K141951 - DLP SILICONE CORONARY ARTERY OSTIAL CAN...

K141951 is the FDA 510(k) clearance for DLP SILICONE CORONARY ARTERY OSTIAL CAN... by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Special 510(k) pathway after a 28-day FDA review.

K141951 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
28d
Days
Class 2
Risk

K141951 is an FDA 510(k) clearance for the DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 15, 2014 after a review of 28 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, Inc. devices

Submission Details

510(k) Number K141951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2014
Decision Date August 15, 2014
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 148
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K141951.
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
CARPENTIER BI-CAVAL FEMORAL CANNULA
K140192 · Medtronic, Inc. · May 2014
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
K140165 · Medtronic, Inc. · May 2014
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
K140208 · Edwards Lifesciences, LLC · Mar 2014