Cleared Traditional

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT

K092486 · Vortex Medical, Inc. · Cardiovascular

Aug 2009

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K092486 is an FDA 510(k) clearance for the VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT, a Tubing, Pump, Cardiopulmonary Bypass (Class II — Special Controls, product code DWE), submitted by Vortex Medical, Inc. (Glens Falls, US). The FDA issued a Cleared decision on August 28, 2009, 15 days after receiving the submission on August 13, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4390.

Submission Details

510(k) Number	K092486 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2009
Decision Date	August 28, 2009
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF