Cleared Traditional

PureFlex Arterial Cannulae

K180979 · Sorin Group Italia S.R.L. · Cardiovascular

Nov 2018

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K180979 is an FDA 510(k) clearance for the PureFlex Arterial Cannulae, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on November 16, 2018, 217 days after receiving the submission on April 13, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K180979 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2018
Decision Date	November 16, 2018
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210