Prelude IDeal Hydrophilic Sheath Introducer

Introducer, Catheter

Merit Medical Systems, Inc.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude Ideal Hydrophilic Sheath Introducer.

Pre-market Notification Details

• Device ID: K173750
• 510k Number: K173750
• Device Name: Prelude IDeal Hydrophilic Sheath Introducer
• Classification: Introducer, Catheter
• Applicant: Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
• Contact: David Thomas
• Correspondent: David Thomas; Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-12-08
• Decision Date: 2018-02-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884450441736	K173750	000
20884450381834	K173750	000
20884450381582	K173750	000
20884450381506	K173750	000
20884450381605	K173750	000
20884450381469	K173750	000
20884450381643	K173750	000
20884450381988	K173750	000
20884450381971	K173750	000
20884450381797	K173750	000
20884450382107	K173750	000
20884450382060	K173750	000
20884450381483	K173750	000
20884450381704	K173750	000
20884450381919	K173750	000
20884450381810	K173750	000
20884450381865	K173750	000
20884450381940	K173750	000
20884450463141	K173750	000
20884450381957	K173750	000
20884450381841	K173750	000
20884450381902	K173750	000
20884450381872	K173750	000
20884450381735	K173750	000
20884450381964	K173750	000
20884450463097	K173750	000
20884450381650	K173750	000
20884450381827	K173750	000
20884450382091	K173750	000
20884450381896	K173750	000
20884450381612	K173750	000
20884450518148	K173750	000
20884450523043	K173750	000
20884450518186	K173750	000
20884450523098	K173750	000
20884450523067	K173750	000
20884450523074	K173750	000
20884450518247	K173750	000
20884450523036	K173750	000
20884450523081	K173750	000
20884450518230	K173750	000
20884450518162	K173750	000
20884450518155	K173750	000
20884450518285	K173750	000
20884450381476	K173750	000
20884450382053	K173750	000
20884450381636	K173750	000
20884450381544	K173750	000
20884450381995	K173750	000
20884450382008	K173750	000
20884450381575	K173750	000
10884450493165	K173750	000
20884450463110	K173750	000
20884450381926	K173750	000
20884450381780	K173750	000
20884450381490	K173750	000
20884450382039	K173750	000
20884450381667	K173750	000
20884450517523	K173750	000
20884450441644	K173750	000
10884450401047	K173750	000
20884450317598	K173750	000
20884450317581	K173750	000
20884450317574	K173750	000
20884450317529	K173750	000
20884450317512	K173750	000
20884450317475	K173750	000
20884450317451	K173750	000
20884450317390	K173750	000
20884450317383	K173750	000
20884450317376	K173750	000
20884450317369	K173750	000
20884450317352	K173750	000
20884450317604	K173750	000
20884450317611	K173750	000
20884450317628	K173750	000
20884450317543	K173750	000
20884450317741	K173750	000
20884450335035	K173750	000
20884450335028	K173750	000
20884450335004	K173750	000
20884450334991	K173750	000
20884450320468	K173750	000
20884450320451	K173750	000
20884450317727	K173750	000
20884450317710	K173750	000
20884450317703	K173750	000
20884450317673	K173750	000
20884450317338	K173750	000
20884450317321	K173750	000
20884450317307	K173750	000
20884450335011	K173750	000
20884450334984	K173750	000
20884450317536	K173750	000
20884450317482	K173750	000
20884450317468	K173750	000
20884450317406	K173750	000
20884450317215	K173750	000
20884450317192	K173750	000
10884450406981	K173750	000
20884450441651	K173750	000
20884450451087	K173750	000
20884450451070	K173750	000
10884450426330	K173750	000
20884450426351	K173750	000
20884450317031	K173750	000
20884450317277	K173750	000
20884450317246	K173750	000
20884450317185	K173750	000
20884450317178	K173750	000
20884450317130	K173750	000
20884450317123	K173750	000
20884450317116	K173750	000
20884450317093	K173750	000
20884450317079	K173750	000
20884450317062	K173750	000
20884450317055	K173750	000
20884450317048	K173750	000
20884450451094	K173750	000