FDA.reportPublic FDA data

Vascular catheter introduction set, nonimplantable

Definition
A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
GUDID devices
9,858
Last updated
2024-03-18 08:20:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANY3840122016-10-20
20884450707269Prelude®Merit Medical Systems, Inc.F2024-03-09
20884450707320Prelude® PROMerit Medical Systems, Inc.F2024-03-09
00884450510209Prelude Prestige™Merit Medical Systems, Inc.A2024-03-07
20801902219033ARROWTELEFLEX INCORPORATEDIPN9293592024-03-07
20801902219071ARROWTELEFLEX INCORPORATEDIPN9293582024-03-07
20884450709508Prelude® PROMerit Medical Systems, Inc.F2024-03-07
20884450693937Prelude IDeal™Merit Medical Systems, Inc.D2024-03-06
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANY3840082016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANY3840102016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANY3840112016-10-20
00382903840212BD Introsyte-N, BD InstaflashBECTON, DICKINSON AND COMPANY3840212016-10-20
00382903840304BD IntrosyteBECTON, DICKINSON AND COMPANY3840302016-10-20
00382903840311BD Introsyte-NBECTON, DICKINSON AND COMPANY3840312016-10-20
20884450709546Prelude® PROMerit Medical Systems, Inc.F2024-03-01
20884450709553Prelude® PROMerit Medical Systems, Inc.F2024-02-27
10607567114170Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IABDATASCOPE CORP.0884-00-0019-12U2024-02-20
10607567114194Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc IDATASCOPE CORP.0884-00-0019-13U2024-02-20
10607567114200Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc DATASCOPE CORP.0884-00-0019-16U2024-02-20
10607567114217Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IABDATASCOPE CORP.0884-00-0019-17U2024-02-20
10607567114224Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABsDATASCOPE CORP.0884-00-0019-21U2024-02-20
10607567114231Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7DATASCOPE CORP.0884-00-0019-22U2024-02-20
10607567114248Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8FrDATASCOPE CORP.0884-00-0019-23U2024-02-20
20801902208594ARROWTELEFLEX INCORPORATEDIPN9241892024-02-19
20884450708334Prelude® PROMerit Medical Systems, Inc.F2024-02-16
M661S010212753Guide Glide II® Guidewire Introducer NeedleSpectra Medical Devices, LLCS01021-2.753L2024-02-12
00690103217483EVOQUEEdwards Lifesciences LLC9850PTUS2024-02-07
00690103217490EVOQUEEdwards Lifesciences LLC9850LSUS2024-02-07
00690103217506EVOQUEEdwards Lifesciences LLC9850DKUS2024-02-07
00690103217513EVOQUEEdwards Lifesciences LLC9850SBUS2024-02-07
00690103217476EVOQUEEdwards Lifesciences LLC9850BAUS2024-02-06
20801902208587ARROWTELEFLEX INCORPORATEDIPN9241882024-02-05
20801902218937ARROWTELEFLEX INCORPORATEDIPN9292292024-01-29
20801902218876ARROWTELEFLEX INCORPORATEDIPN9292042024-01-24
20801902218883ARROWTELEFLEX INCORPORATEDIPN9292052024-01-24
20884450708433Prelude® PROMerit Medical Systems, Inc.108844507084362024-01-24
04035479116644Selectra Accessory KitBIOTRONIK SE & Co. KG3755182014-08-27
20884450684638Prelude IDeal™Merit Medical Systems, Inc.108844506846312024-01-17
00382903840403BD IntrosyteBECTON, DICKINSON AND COMPANY3840402016-10-20
00382903840502BD IntrosyteBECTON, DICKINSON AND COMPANY3840502016-10-20
00840368514326TYPENEX Sol-Millennium Medical, Inc.MS01032024-01-04
00840368514364TYPENEX SOL-MILLENNIUM MEDICAL INCMS22032024-01-04
20801902218791ARROWTELEFLEX INCORPORATEDIPN9290982024-01-04
20801902218807ARROWTELEFLEX INCORPORATEDIPN9290992024-01-04
20801902206705ARROWTELEFLEX INCORPORATEDIPN9235982022-01-05
20801902210986ARROWTELEFLEX INCORPORATEDIPN9251002022-05-27
20801902211167ARROWTELEFLEX INCORPORATEDIPN9251042022-05-27
20801902211174ARROWTELEFLEX INCORPORATEDIPN9251052022-05-27
20801902211181ARROWTELEFLEX INCORPORATEDIPN9251062022-05-27
20801902214298ARROWTELEFLEX INCORPORATEDIPN9275502023-01-25
20841156103030VSITELEFLEX INCORPORATEDIPN0295002019-07-23
10884450770761Prelude Roadster™Merit Medical Systems, Inc.008844507707642023-12-13
00884450510322Prelude Prestige™Merit Medical Systems, Inc.108844505103292023-12-13
20884450614130Prelude®Merit Medical Systems, Inc.108844506141332023-12-09
20801902218494ARROWTELEFLEX INCORPORATEDIPN9290942023-12-07
20801902218500ARROWTELEFLEX INCORPORATEDIPN9290952023-12-07
20801902218432ARROWTELEFLEX INCORPORATEDIPN9290932023-12-06
00884450489635Prelude SNAP™Merit Medical Systems, Inc.108844504896322023-11-17
00884450489581Prelude SNAP™Merit Medical Systems, Inc.108844504895882023-11-10
20884450518223Prelude IDeal™Merit Medical Systems, Inc.108844505182262023-11-07
20801902217121ARROWTELEFLEX INCORPORATEDIPN9287652023-11-03
00884450510681Prelude Prestige™Merit Medical Systems, Inc.108844505106882023-11-02
20884450614536Prelude®Merit Medical Systems, Inc.108844506145392023-10-31
00813502012729ImpellaAbiomed, Inc.10005342023-10-27
00813502012736ImpellaAbiomed, Inc.10005352023-10-27
00813502013474ImpellaAbiomed, Inc.10005502023-10-27
10884450770778Prelude Roadster™Merit Medical Systems, Inc.008844507707712023-10-28
20884450693432Prelude IDeal™Merit Medical Systems, Inc.108844506934352023-10-27
00884450510520Prelude Prestige™Merit Medical Systems, Inc.108844505105272023-10-14
M661S01318275Guide Glide II® Guidewire Introducer Needle Spectra Medical Devices, LLCS01318-2.759LF2023-10-13
20801902211624ARROWTELEFLEX INCORPORATEDIPN9261542023-10-12
20801902212171ARROWTELEFLEX INCORPORATEDIPN9266552023-10-12
M661S01321275Guide Glide II® Guidewire Introducer NeedleSpectra Medical Devices, LLCS01321-2.759LF2023-10-12
10884450770785Prelude Roadster™Merit Medical Systems, Inc.008844507707882023-10-11
20801902217084ARROWTELEFLEX INCORPORATEDIPN9287472023-10-10
20884450693418Prelude IDeal™Merit Medical Systems, Inc.108844506934112023-10-10
10884450770754Prelude Roadster™Merit Medical Systems, Inc.008844507707572023-10-05
20801902211617ARROWTELEFLEX INCORPORATEDIPN9261532022-12-14
20801902211631ARROWTELEFLEX INCORPORATEDIPN9261552022-12-14
20801902211648ARROWTELEFLEX INCORPORATEDIPN9261562022-12-14