Cleared Traditional

K132451 - SARNS SOFT-FLOW AORTIC CANNULA

K132451 is an FDA 510(k) clearance for SARNS SOFT-FLOW AORTIC CANNULA, manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K132451 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Feb 2014
Decision
196d
Days
Class 2
Risk

K132451 is an FDA 510(k) clearance for the SARNS SOFT-FLOW AORTIC CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Elkton, US). The FDA issued a Cleared decision on February 18, 2014 after a review of 196 days - an extended review 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: 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 Terumo Cardiovascular Systems Corp. devices

FDA 510(k) Submission Details - K132451

510(k) Number K132451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2013
Decision Date February 18, 2014
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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 K132451.
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
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FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
K140208 · Edwards Lifesciences, LLC · Mar 2014
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
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K132995 · Medtronic, Inc. · Oct 2013
DLP CORONARY OSTIAL PERFUSION CANNULAE
K131269 · Medtronic, Inc. · Jul 2013