Cleared Traditional

K162215 - Aortic Arch Cannulae

K162215 is an FDA 510(k) clearance for Aortic Arch Cannulae, manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K162215 · Sorin Group Italia S.R.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
312d
Days
Class 2
Risk

K162215 is an FDA 510(k) clearance for the Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on June 16, 2017 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sorin Group Italia S.R.L. devices

FDA 510(k) Submission Details - K162215

510(k) Number K162215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date June 16, 2017
Days to Decision 312 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
187d slower than avg
Panel avg: 125d · This submission: 312d
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 Consultant

Parexel Consulting, LLC
SCOTT LIGHT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 297
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K162215.
Bio-Medicus Adult Cannulae and Introducer
K180453 · Medtronic, Inc. · Mar 2018
Bio-Medicus Adult Cannulae Kit
K180456 · Medtronic, Inc. · Mar 2018
Tubing Pack
K171979 · Medtronic, Inc. · Oct 2017
Tubing Pack
K171308 · Medtronic, Inc. · Jun 2017
Protek Solo 24 Fr Venous Cannula Set
K162214 · Cardiacassist, Inc. · Nov 2016
PROTEK Duo 31 Fr. Veno-Venous Cannula Set
K160257 · Cardiacassist, Inc. · Mar 2016