Cleared Traditional

K120072 - VENOUS DRAINAGE CANNULA WITH DURAFLO CO...

K120072 is an FDA 510(k) clearance for VENOUS DRAINAGE CANNULA WITH DURAFLO CO..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K120072 · Edwards Lifesciences, LLC · Cardiovascular device
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May 2012
Decision
119d
Days
Class 2
Risk

K120072 is an FDA 510(k) clearance for the VENOUS DRAINAGE CANNULA WITH DURAFLO COATING. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 119 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K120072

510(k) Number K120072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2012
Decision Date May 08, 2012
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
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 283
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K120072.
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
K113411 · Edwards Lifesciences, LLC · Jun 2012
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
K120987 · Medtronic, Inc. · Jun 2012
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
K120612 · Medtronic, Inc. · May 2012
MEDLINE VESSEL CANNULA
K111147 · Medline Industries, Inc. · Jul 2011
HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
K102532 · Maquet Cardiopulmonary, AG · Feb 2011
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
K102420 · Edwards Lifesciences, LLC · Oct 2010