Cleared Traditional

K132811 - SARNS SOFT-FLOW EXTENDED AORTIC CANNULA

K132811 is an FDA 510(k) clearance for SARNS SOFT-FLOW EXTENDED AORTIC CANNULA, manufactured by Terumo Cardiovascular Systems Corporation. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K132811 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
171d
Days
Class 2
Risk

K132811 is an FDA 510(k) clearance for the SARNS SOFT-FLOW EXTENDED AORTIC CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on February 27, 2014 after a review of 171 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 Corporation devices

FDA 510(k) Submission Details - K132811

510(k) Number K132811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2013
Decision Date February 27, 2014
Days to Decision 171 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
46d slower than avg
Panel avg: 125d · This submission: 171d
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 329
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K132811.
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
ANGIOVAC CANNULA
K133445 · Vortex Medical, Inc. · Mar 2014
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
K140208 · Edwards Lifesciences, LLC · Mar 2014
SARNS SOFT-FLOW AORTIC CANNULA
K132451 · Terumo Cardiovascular Systems Corp. · Feb 2014
15 FR. TANDEMHEART ARTERIAL CANNULA
K133293 · Cardiacassist, Inc. · Feb 2014
SARNS HIGH FLOW AORTIC ARCH CANNULA
K133151 · Terumo Cardiovascular Systems Corp. · Feb 2014