ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

CALIFORNIA MEDICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for Antegrade/retrograde Perfusion Adapter With Or Without Pressure Line.

Pre-market Notification Details

• Device ID: K993818
• 510k Number: K993818
• Device Name: ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine, CA 92614
• Contact: Mehmet Bicakci
• Correspondent: Mehmet Bicakci; CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine, CA 92614
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-10
• Decision Date: 2000-02-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10803622106603	K993818	000
10803622103794	K993818	000
10803622103787	K993818	000
10803622103565	K993818	000
10803622103558	K993818	000
10803622103541	K993818	000
10803622103534	K993818	000
10803622103527	K993818	000
10803622103510	K993818	000