Cleared Traditional

K013013 - MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.

K013013 is an FDA 510(k) clearance for MEDTRONIC DLP ARTERIAL CANNULA WITH 3D ..., manufactured by Medtronic Cardiac Surgical Products. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K013013 · Medtronic Cardiac Surgical Products · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
88d
Days
Class 2
Risk

K013013 is an FDA 510(k) clearance for the MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic Cardiac Surgical Products (Grand Rapids, US). The FDA issued a Cleared decision on December 4, 2001 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K013013

510(k) Number K013013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2001
Decision Date December 04, 2001
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 404
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K013013.
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · Edwards Lifesciences, LLC · Apr 2002
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
K014303 · Jostra AG · Mar 2002
JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
K013944 · Jostra AG · Feb 2002
JOSTRA ARTERIAL PERFUSION CANNULAE
K012774 · Jostra AG · Nov 2001
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
K012617 · Jostra AG · Nov 2001
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
K001509 · Cobe Cardiovascular, Inc. · Oct 2001
K013013 · MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
Download PDF FDA Summary Medtronic Cardiac Sur…