Cleared Traditional

VORTEX CANNULA

K091304 · Vortex Medical, Inc. · Cardiovascular

Jul 2009

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K091304 is an FDA 510(k) clearance for the VORTEX CANNULA, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Vortex Medical, Inc. (Norwell, US). The FDA issued a Cleared decision on July 2, 2009, 59 days after receiving the submission on May 4, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K091304 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2009
Decision Date	July 02, 2009
Days to Decision	59 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