VENOUS RETURN CANNULA W/CUFF 91039

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Venous Return Cannula W/cuff 91039.

Pre-market Notification Details

• Device ID: K854487
• 510k Number: K854487
• Device Name: VENOUS RETURN CANNULA W/CUFF 91039
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501
• Contact: Ronald Williams
• Correspondent: Ronald Williams; DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-11-08
• Decision Date: 1986-02-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994494430	K854487	000