SeQure® NF And SeQure® Microcatheters

Catheter, Intravascular, Diagnostic

Accurate Medical Therapeutics Ltd.

The following data is part of a premarket notification filed by Accurate Medical Therapeutics Ltd. with the FDA for Sequre® Nf And Sequre® Microcatheters.

Pre-market Notification Details

• Device ID: K173430
• 510k Number: K173430
• Device Name: SeQure® NF And SeQure® Microcatheters
• Classification: Catheter, Intravascular, Diagnostic
• Applicant: Accurate Medical Therapeutics Ltd. 21 Habarzel Street Tel-aviv, IL 6971029
• Contact: Eran Miller
• Correspondent: Orly Maor; Orly Maor 25A Sirkin Street Kfar Saba, IL 4442156
• Product Code: DQO
• CFR Regulation Number: 870.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-02
• Decision Date: 2018-01-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290017268583	K173430	000
07290017268019	K173430	000
07290017268026	K173430	000
07290017268033	K173430	000
07290017268040	K173430	000
07290017268057	K173430	000
07290017268064	K173430	000
07290017268071	K173430	000
07290017268088	K173430	000
07290017268507	K173430	000
07290017268514	K173430	000
07290017268521	K173430	000
07290017268538	K173430	000
07290017268545	K173430	000
07290017268552	K173430	000
07290017268569	K173430	000
07290017268576	K173430	000
07290017268002	K173430	000