Cleared Special

K140208 - FERM-FLEX AND FEM-FLEX II ( FEMORAL ACC...

K140208 is an FDA 510(k) clearance for FERM-FLEX AND FEM-FLEX II ( FEMORAL ACC..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 36-day FDA review.

K140208 · Edwards Lifesciences, LLC · Cardiovascular device
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Mar 2014
Decision
36d
Days
Class 2
Risk

K140208 is an FDA 510(k) clearance for the FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, A.... 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 March 5, 2014 after a review of 36 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K140208

510(k) Number K140208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2014
Decision Date March 05, 2014
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
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 283
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K140208.
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
K141951 · Medtronic, Inc. · Aug 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
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
K132811 · Terumo Cardiovascular Systems Corporation · Feb 2014
SARNS SOFT-FLOW AORTIC CANNULA
K132451 · Terumo Cardiovascular Systems Corp. · Feb 2014
SARNS HIGH FLOW AORTIC ARCH CANNULA
K133151 · Terumo Cardiovascular Systems Corp. · Feb 2014