NC Gallant PTCA Catheter

Catheters, Transluminal Coronary Angioplasty, Percutaneous

MEDINOL LTD.

The following data is part of a premarket notification filed by Medinol Ltd. with the FDA for Nc Gallant Ptca Catheter.

Pre-market Notification Details

• Device ID: K162434
• 510k Number: K162434
• Device Name: NC Gallant PTCA Catheter
• Classification: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Applicant: MEDINOL LTD. KIRYAT ATIDIM, BUILDING 8 Tel Aviv, IL 6158101
• Contact: Michal Hershkovitz
• Correspondent: H. Semih Oktay; CardioMed Device Consultants 5523 Research Park Drive Suite 205 Baltimore, MD 21228
• Product Code: LOX
• CFR Regulation Number: 870.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-31
• Decision Date: 2017-01-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290107011600	K162434	000
07290107011785	K162434	000
07290107011792	K162434	000
07290107011808	K162434	000
07290107011815	K162434	000
07290107011822	K162434	000
07290107011839	K162434	000
07290107011846	K162434	000
07290107011853	K162434	000
07290107011860	K162434	000
07290107011877	K162434	000
07290107011884	K162434	000
07290107011891	K162434	000
07290107011907	K162434	000
07290107011914	K162434	000
07290107011778	K162434	000
07290107011761	K162434	000
07290107011754	K162434	000
07290107011617	K162434	000
07290107011624	K162434	000
07290107011631	K162434	000
07290107011648	K162434	000
07290107011655	K162434	000
07290107011662	K162434	000
07290107011679	K162434	000
07290107011686	K162434	000
07290107011693	K162434	000
07290107011709	K162434	000
07290107011716	K162434	000
07290107011723	K162434	000
07290107011730	K162434	000
07290107011747	K162434	000
07290107011921	K162434	000
07290107011938	K162434	000
07290107011945	K162434	000
07290107012126	K162434	000
07290107012133	K162434	000
07290107012140	K162434	000
07290107012157	K162434	000
07290107012164	K162434	000
07290107012171	K162434	000
07290107012188	K162434	000
07290107012195	K162434	000
07290107012201	K162434	000
07290107012218	K162434	000
07290107012225	K162434	000
07290107012232	K162434	000
07290107012249	K162434	000
07290107012256	K162434	000
07290107012119	K162434	000
07290107012102	K162434	000
07290107012096	K162434	000
07290107011952	K162434	000
07290107011969	K162434	000
07290107011976	K162434	000
07290107011983	K162434	000
07290107011990	K162434	000
07290107012003	K162434	000
07290107012010	K162434	000
07290107012027	K162434	000
07290107012034	K162434	000
07290107012041	K162434	000
07290107012058	K162434	000
07290107012065	K162434	000
07290107012072	K162434	000
07290107012089	K162434	000
07290107012263	K162434	000