Cleared Traditional

ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.

K900994 · Dlp, Inc. · Cardiovascular

Aug 1990

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K900994 is an FDA 510(k) clearance for the ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT., a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on August 15, 1990, 166 days after receiving the submission on March 2, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K900994 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 1990
Decision Date	August 15, 1990
Days to Decision	166 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

Device Classification

Product Code	DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4290