V•Stick™ Vascular Access Set
V·Stick Vascular Access Set supports introduction and placement of guidewires or catheters. It combines a coaxial introducer, entry needle and access guidewire as separate parts of the…
V·Stick Vascular Access Set supports introduction and placement of guidewires or catheters. It combines a coaxial introducer, entry needle and access guidewire as separate parts of the vascular access assembly.
The guidewire is 0.018 inch by 40 cm, with a nitinol core, stainless-steel coil tip and articulatable tip. The needle provides the initial access component, while the wire and introducer support device passage.
Listed Item
V- Stick Vascular Access Set 5F with Talwire
Introducer and Needle Options
The introducer is offered in 4F or 5F configurations with a 3F standard or stiff dilator. The 21-gauge entry needle has echogenic or nonechogenic tip options. A listed 5F set with Talwire is one configuration within the range.
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K253741 |
| Record published | 2016-09-16 |
| Record revised | 2026-05-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry and away from sunlight |
| Packaging | Box of 10 |
| Distribution end date | 2026-03-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 391504500E | 4F | In distribution |
| 391505400E | 5F | In distribution |
| 391604000E | 4F | In distribution |
| 391605400E | 5F | In distribution |
| 391604300E | 4F | In distribution |
| 391605300E | 5F | In distribution |
| 391505500E | 5F | In distribution |
| 391604500E | 4F | In distribution |
| 391604400E | 4F | In distribution |
| 391505300E | 5F | In distribution |
| 391605000E | 5F | In distribution |
| 391504300E | 4F | In distribution |
| 391504400E | 4F | In distribution |
| 391505000E | 5F | In distribution |
| 391605500E | 5F | Withdrawn |
| 391505300E | 5F | Withdrawn |
| 390204400E | 4F | Withdrawn |
| 391605400E | 5F | Withdrawn |
| 391705400E | 5F | Withdrawn |
| 391504300E | 4F | Withdrawn |
| 391604300E | 4F | Withdrawn |
| 391604400E | 4F | Withdrawn |
| 391504400E | 4F | Withdrawn |
| 391605300E | 5F | Withdrawn |
| 391504000E | 4F | Withdrawn |
| 391505400E | 5F | Withdrawn |
| 391704400E | 4F | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253741 | 2025-12-15 |
| K241145 | 2024-08-01 |
| K233432 | 2023-12-08 |
| K230631 | 2023-05-22 |
| K213638 | 2021-12-10 |
| K213002 | 2021-10-14 |
| K202141 | 2021-01-15 |
| K201489 | 2020-12-22 |
| K141969 | 2014-12-19 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-07-08 | Class II | Device Design | As a result of design changes, sheaths have exhibited cracking/breaking at the tips. | 20 units | |
| 2020-12-10 | Class II | Process change control | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or rever | 863 unit | 2023-01-31 |
| 2020-12-10 | Class II | Process change control | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or rever | 583 units | 2023-01-31 |
| 2020-12-10 | Class II | Process change control | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or rever | 187 units | 2023-01-31 |
| 2020-12-10 | Class II | Process change control | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or rever | 247 units | 2023-01-31 |
| 2020-12-10 | Class II | Process change control | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or rever | 1759 units | 2023-01-31 |
| 2020-12-10 | Class II | Process change control | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or rever | 483 units | 2023-01-31 |
| 2016-09-08 | Class II | Nonconforming Material/Component | The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath | 200 units | 2017-06-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.