ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Antegrade/retrograde Y W/integral Selector Swit..

Pre-market Notification Details

• Device ID: K900994
• 510k Number: K900994
• Device Name: ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
• Classification: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
• Applicant: DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501
• Contact: Ronald A Williams
• Correspondent: Ronald A Williams; DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501
• Product Code: DTL
• CFR Regulation Number: 870.4290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-03-02
• Decision Date: 1990-08-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994845249	K900994	000
20613994845195	K900994	000
20613994845171	K900994	000
20613994677611	K900994	000