FDA.reportPublic FDA data

Non-vascular catheter introduction set

Definition
A collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.
GUDID devices
57
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00661392008960LSL HEALTHCARELSL Industries, LLC1042025-10-30
00817295020442InradInrad510182016-12-01
00817295020459InradInrad510192016-12-01
00817295020466InradInrad521182016-12-01
00817295020473InradInrad520182016-12-01
00817295020480InradInrad524192016-12-01
00817295020497InradInrad522192016-12-01
00817295020503InradInrad521192016-12-01
00817295020510InradInrad550182016-12-01
00817295020527InradInrad570182016-12-01
00817295020534InradInrad550192016-12-01
00817295020541InradInrad570192016-12-01
00817295020596InradInrad500182016-12-01
00817295020602InradInrad500192016-12-01
00818788020895EpimedEPIMED INTERNATIONAL, INC134-14202017-10-30
00818788020901EpimedEPIMED INTERNATIONAL, INC134-14302017-10-30
00818788020918EpimedEPIMED INTERNATIONAL, INC134-14352017-10-30
00818788020925EpimedEPIMED INTERNATIONAL, INC134-14552017-10-30
00818788020932EpimedEPIMED INTERNATIONAL, INC135-14202017-10-30
00818788020949EpimedEPIMED INTERNATIONAL, INC135-14552017-10-30
00818788020956EpimedEPIMED INTERNATIONAL, INC135-17352017-10-30
00818788021007EpimedEPIMED INTERNATIONAL, INC137-18352017-10-30
00818788023698Epimed International, Inc.EPIMED INTERNATIONAL, INC138-14272022-05-05
00842102106354Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle FLEXBAR MACHINE CORPORATIOND10042017-03-24
00858690006433PERCUTANEOUS INTRO NEEDLE F/GRANFAC CORP.PIN-152017-05-02
00884450013564MAK-NV™Merit Medical Systems, Inc.008844500135642018-05-02
00884450013571MAK-NV™Merit Medical Systems, Inc.008844500135712018-05-02
00884450013588MAK-NV™Merit Medical Systems, Inc.008844500135882018-05-02
00884450013595MAK-NV™Merit Medical Systems, Inc.008844500135952018-05-02
00884450013601MAK-NV™Merit Medical Systems, Inc.008844500136012018-05-02
00884450015636MAK-NV™Merit Medical Systems, Inc.008844500156362018-05-02
00884450015643MAK-NV™Merit Medical Systems, Inc.008844500156432018-05-02
00884450088784MAK-NV™Merit Medical Systems, Inc.008844500887842018-05-02
00884450088791MAK-NV™Merit Medical Systems, Inc.008844500887912018-05-02
00884450088807MAK-NV™Merit Medical Systems, Inc.008844500888072018-05-02
00884450088814MAK-NV™Merit Medical Systems, Inc.008844500888142018-05-02
00884450088821MAK-NV™Merit Medical Systems, Inc.008844500888212018-05-02
00884450088838MAK-NV™Merit Medical Systems, Inc.008844500888382018-05-02
00884450088845MAK-NV™Merit Medical Systems, Inc.008844500888452018-05-02
00884450088852MAK-NV™Merit Medical Systems, Inc.008844500888522018-05-02
00884450088869MAK-NV™Merit Medical Systems, Inc.008844500888692018-05-02
00884450088876MAK-NV™Merit Medical Systems, Inc.008844500888762018-05-02
00884450088883MAK-NV™Merit Medical Systems, Inc.008844500888832018-05-02
00884450088890MAK-NV™Merit Medical Systems, Inc.008844500888902018-05-02
00884450088906MAK-NV™Merit Medical Systems, Inc.008844500889062018-05-02
00884450088913MAK-NV™Merit Medical Systems, Inc.008844500889132018-05-02
00886333004515Skater™ Introducer SystemARGON MEDICAL DEVICES, INC.6515063002022-07-14
00886333004522Skater™ Introducer SystemARGON MEDICAL DEVICES, INC.6515060002022-07-14
00886333004539Skater™ Introducer SystemARGON MEDICAL DEVICES, INC.6555060002022-07-14
00886333223336Skater™ Introducer SetARGON MEDICAL DEVICES, INC.6510060002022-07-14
00886333223350Skater™ Introducer SetARGON MEDICAL DEVICES, INC.6510063002022-07-14
08033003344965NI-FLEXH.S. HOSPITAL SERVICE SPANI-FLEX2021-03-01
10884389579985MedlineMEDLINE INDUSTRIES, INC.DYNDINSERTKIT2022-11-30
10884450484491Prelude SNAP 165™Merit Medical Systems, Inc.108844504844912020-12-03
10885403193026PleurXCAREFUSION 2200, INC50-72622017-06-12
H7877001023310StarBurstANGIODYNAMICS, INC.7001023312018-07-26
10857808005419Aspire Introducer NeedleASPIRE BARIATRICS, INC.100-00352018-08-13