VSI Micro-Introducer Kit

Introducer, Catheter

Vascular Solutions, Inc.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vsi Micro-introducer Kit.

Pre-market Notification Details

• Device ID: K180913
• 510k Number: K180913
• Device Name: VSI Micro-Introducer Kit
• Classification: Introducer, Catheter
• Applicant: Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369
• Contact: Jake Schultz
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2018-04-09
• Decision Date: 2018-05-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20841156102705	K180913	000
20841156102989	K180913	000
20841156103009	K180913	000
20841156103092	K180913	000
20841156103153	K180913	000
20841156103160	K180913	000
20841156103276	K180913	000
20841156103337	K180913	000
20841156102729	K180913	000
20841156102767	K180913	000
20841156102835	K180913	000
20841156102880	K180913	000
20841156102903	K180913	000
20841156102941	K180913	000
20841156102958	K180913	000
20841156102934	K180913	000
20841156102828	K180913	000
20841156102811	K180913	000
20841156102712	K180913	000
20841156102866	K180913	000
20841156103047	K180913	000
20841156103078	K180913	000
20841156103108	K180913	000
20841156103207	K180913	000
20841156103221	K180913	000
20841156103238	K180913	000
20841156103245	K180913	000
20841156103252	K180913	000
20841156103382	K180913	000
20841156102736	K180913	000
20841156102750	K180913	000
20841156102774	K180913	000
20841156102965	K180913	000
20841156103016	K180913	000
20841156103023	K180913	000
20841156102668	K180913	000
20841156102675	K180913	000
20841156102682	K180913	000
20841156102699	K180913	000
20841156102781	K180913	000
20841156102798	K180913	000
20841156102859	K180913	000
20841156102873	K180913	000
20841156102897	K180913	000
20841156102910	K180913	000
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20841156102644	K180913	000
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20841156103054	K180913	000
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20841156103115	K180913	000
20841156103122	K180913	000
20841156103139	K180913	000
20841156103184	K180913	000
20841156103269	K180913	000
20841156103313	K180913	000
20841156103351	K180913	000
20841156103368	K180913	000
20841156103375	K180913	000
20841156102606	K180913	000
20841156102613	K180913	000
20841156102620	K180913	000
20841156105034	K180913	000