Cleared Traditional

SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)

K900753 · Shiley, Inc. · Cardiovascular

Apr 1990

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K900753 is an FDA 510(k) clearance for the SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT), a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on April 10, 1990, 53 days after receiving the submission on February 16, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K900753 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 1990
Decision Date	April 10, 1990
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

Device Classification

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