Cleared Traditional

PICSO CANNULA, CATALOG CODE 94315

K897022 · Dlp, Inc. · Cardiovascular

Mar 1990

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K897022 is an FDA 510(k) clearance for the PICSO CANNULA, CATALOG CODE 94315, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on March 16, 1990, 87 days after receiving the submission on December 19, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K897022 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 1989
Decision Date	March 16, 1990
Days to Decision	87 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