FDA.reportPublic FDA data

Fascial tissue dilator, single-use

Definition
A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.
GUDID devices
387
Last updated
2026-09-04 23:09:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00884450440476ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440483ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440506ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440513ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440520ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440537ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440568ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440575ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440582ByrdMerit Medical Systems, Inc.A2026-08-21
00884450440599ByrdMerit Medical Systems, Inc.A2026-08-21
00190376666334ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.266-00-100-N-S2025-05-27
00817640020509Posi-Stick Introducer SetURESIL, LLCPS2-1S2022-06-03
00884450441619Evolution® RLMerit Medical Systems, Inc.B2026-03-11
00884450441626Evolution® RLMerit Medical Systems, Inc.B2026-03-10
00884450441749Evolution® RLMerit Medical Systems, Inc.B2026-03-11
00884450441756Evolution® RLMerit Medical Systems, Inc.B2026-03-11
00884450441763Evolution® Shortie RLMerit Medical Systems, Inc.B2026-03-05
00884450441770SteadySheath®Merit Medical Systems, Inc.B2026-03-06
00884450441787SteadySheath®Merit Medical Systems, Inc.B2026-03-21
00884450441794SteadySheath®Merit Medical Systems, Inc.B2026-03-06
00884450441800SteadySheath® ShortieMerit Medical Systems, Inc.B2026-03-06
00884450441817SteadySheath® ShortieMerit Medical Systems, Inc.B2026-05-08
00886333004904Screw DilatorARGON MEDICAL DEVICES, INC.6307380252016-09-12
00886333004911Screw DilatorARGON MEDICAL DEVICES, INC.6308380252016-09-12
00886333004928Screw DilatorARGON MEDICAL DEVICES, INC.6309380252016-09-12
00886333004935Screw DilatorARGON MEDICAL DEVICES, INC.6310380252016-09-12
00886333004942Screw DilatorARGON MEDICAL DEVICES, INC.6312380252016-09-12
00886333004959Screw DilatorARGON MEDICAL DEVICES, INC.6314380252016-09-12
00886333004966Screw DilatorARGON MEDICAL DEVICES, INC.6316470252016-09-12
00886333210312Vessel DilatorARGON MEDICAL DEVICES, INC.3922992016-09-10
00886333210329Vessel DilatorARGON MEDICAL DEVICES, INC.3923002016-09-10
00886333210336Vessel DilatorARGON MEDICAL DEVICES, INC.3923012016-09-10
00886333210343Vessel DilatorARGON MEDICAL DEVICES, INC.3923022016-09-10
00886333210350Vessel DilatorARGON MEDICAL DEVICES, INC.3923032016-09-10
00886333210367Vessel DilatorARGON MEDICAL DEVICES, INC.3923042016-09-10
00886333210374Vessel DilatorARGON MEDICAL DEVICES, INC.3923052016-09-10
00886333210381Vessel DilatorARGON MEDICAL DEVICES, INC.3923062016-09-10
00886333210398Vessel DilatorARGON MEDICAL DEVICES, INC.3923072016-09-10
00886333210404Vessel DilatorARGON MEDICAL DEVICES, INC.3923082016-09-10
00886333210411Vessel DilatorARGON MEDICAL DEVICES, INC.3923092016-09-10
00886333210428Vessel DilatorARGON MEDICAL DEVICES, INC.3923102016-09-10
00886333210435Vessel DilatorARGON MEDICAL DEVICES, INC.3923542016-09-10
00886333210442Vessel Dilator with Feathered TipARGON MEDICAL DEVICES, INC.3923552016-09-10
00886333210459Vessel Dilator with Feathered TipARGON MEDICAL DEVICES, INC.3923562016-09-10
00886333210466Vessel Dilator with Feathered TipARGON MEDICAL DEVICES, INC.3923572016-09-10
00886333210510Vessel Dilator with CollarARGON MEDICAL DEVICES, INC.3924102016-09-10
00886333210527Vessel Dilator with CollarARGON MEDICAL DEVICES, INC.3924112016-09-10
00886333210534Vessel Dilator with CollarARGON MEDICAL DEVICES, INC.3924122016-09-10
00886333210541Vessel Dilator with CollarARGON MEDICAL DEVICES, INC.3924132016-09-10
00886333210558Vessel Dilator with CollarARGON MEDICAL DEVICES, INC.3924142016-09-10
08714729295846NABOSTON SCIENTIFIC CORPORATIONM0014815402016-09-19
08714729295860NABOSTON SCIENTIFIC CORPORATIONM0014825002016-09-19
08714729295884NABOSTON SCIENTIFIC CORPORATIONM0014825202016-09-19
10827002237374EvolutionCook Vandergrift Inc.G237372016-09-24
10827002237466EvolutionCook Vandergrift Inc.G237462016-09-24
10827002237473EvolutionCook Vandergrift Inc.G237472016-09-24
10827002465395EvolutionCook Vandergrift Inc.G465392016-09-24
10827002465401EvolutionCook Vandergrift Inc.G465402016-09-24
10827002465418EvolutionCook Vandergrift Inc.G465412016-09-24
H862PS2000Posi-Stick Introducer SetURESIL, LLCPS2-002016-08-29
H862PS21S0Posi-Stick Introducer SetURESIL, LLCPS2-1S2016-08-30
H862PS21SNC0Posi-Stick Introducer SetURESIL, LLCPS2-1S2019-06-19
H862PS2350Posi-Stick Introducer SetURESIL, LLCPS2-352016-08-30
H862PS235SW0Posi-Stick Introducer SetURESIL, LLCPS2-35SW2016-08-31
H862PS2380Posi-Stick Introducer SetURESIL, LLCPS2-382016-08-31
H862PS238SW0Posi-Stick Introducer SetURESIL, LLCPS2-38SW2016-08-31
10884450441784SteadySheath®Merit Medical Systems, Inc.B2026-03-21
10884450441616Evolution® RLMerit Medical Systems, Inc.B2026-03-11
10884450441746Evolution® RLMerit Medical Systems, Inc.B2026-03-11
10884450441753Evolution® RLMerit Medical Systems, Inc.B2026-03-11
10884450441623Evolution® RLMerit Medical Systems, Inc.B2026-03-10
10884450441777SteadySheath®Merit Medical Systems, Inc.B2026-03-06
10884450441791SteadySheath®Merit Medical Systems, Inc.B2026-03-06
10884450441807SteadySheath® ShortieMerit Medical Systems, Inc.B2026-03-06
10884450441760Evolution® Shortie RLMerit Medical Systems, Inc.B2026-03-05
00190376654263Valence Robotic Navigation SystemALPHATEC SPINE, INC.267-00-300-VN2026-02-26
00190376661384SafeOp 3ALPHATEC SPINE, INC.AIX1360-VN-S2026-02-26
00190376476131ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.266-00-100-N2024-03-28
10817640020506Posi-Stick Introducer SetURESIL, LLCPS2-1S2022-06-03
00827002132184CookCOOK INCORPORATEDG132182021-11-15