CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE

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 Cardioplegia Adapters, Vessel Canulae, And Aortic Root Cannulae.

Pre-market Notification Details

• Device ID: K972503
• 510k Number: K972503
• Device Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• 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: 1997-07-03
• Decision Date: 1997-08-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
38033178019621	K972503	000
38033178017269	K972503	000
38033178017276	K972503	000
38033178017313	K972503	000
38033178019027	K972503	000
38033178019034	K972503	000
10803622103008	K972503	000
10803622103015	K972503	000
10803622103022	K972503	000
10803622103039	K972503	000
10803622103046	K972503	000
38033178017252	K972503	000
38033178017245	K972503	000
38033178019638	K972503	000
38033178019645	K972503	000
38033178019652	K972503	000
38033178019669	K972503	000
38033178019676	K972503	000
38033178017191	K972503	000
38033178017207	K972503	000
38033178017214	K972503	000
38033178017221	K972503	000
38033178017238	K972503	000
10803622103053	K972503	000
10803622103060	K972503	000
10803622106306	K972503	000
10803622106313	K972503	000
10803622106504	K972503	000
10803622106511	K972503	000
10803622106573	K972503	000
10803622106580	K972503	000
10803622106597	K972503	000
10803622112857	K972503	000
10803622124423	K972503	000
10803622124430	K972503	000
10803622106290	K972503	000
10803622106283	K972503	000
10803622103077	K972503	000
10803622103084	K972503	000
10803622103091	K972503	000
10803622103114	K972503	000
10803622106221	K972503	000
10803622106238	K972503	000
10803622106245	K972503	000
10803622106252	K972503	000
10803622106269	K972503	000
10803622106276	K972503	000
10803622128353	K972503	000