Cleared Traditional

CATHETER TWO STAGE VENOUS RETURN

K915268 · Dlp, Inc. · Cardiovascular

Jul 1992

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K915268 is an FDA 510(k) clearance for the CATHETER TWO STAGE VENOUS RETURN, 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 July 27, 1992, 245 days after receiving the submission on November 25, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K915268 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 1991
Decision Date	July 27, 1992
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

Device Classification

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