Shoocin
"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The Puncture Needle incorporates a lumen, which…
“The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling the wire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator.
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 | Lepu Medical Technology (Beijing) Co., Ltd., China |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Manufacturer |
| Record published | 2018-08-17 |
| Record revised | 2024-03-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RS061118 | In distribution | |
| RS041118S-II | In distribution | |
| LS082338 | In distribution | |
| FS051138 | In distribution | |
| RS070718 | In distribution | |
| RS050725S | In distribution | |
| RS060718S | In distribution | |
| RS040718 | In distribution | |
| FS081135-0 | In distribution | |
| RS070525 | In distribution | |
| LS081638 | In distribution | |
| RS050718S | In distribution | |
| FS061138 | In distribution | |
| RS070521 | In distribution | |
| RS050518S | In distribution | |
| RS061118S | In distribution | |
| RS040725S-II | In distribution | |
| RS040725 | In distribution | |
| RS040718S-II | In distribution | |
| RS071118S-II | In distribution | |
| RS040521 | In distribution | |
| FS060535 | In distribution | |
| RS040518 | In distribution | |
| LS072338 | In distribution | |
| RS040718S | In distribution | |
| FS050535 | In distribution | |
| RS040518S-II | In distribution | |
| RS040721S | In distribution | |
| FS051135 | In distribution | |
| RS061118S-II | In distribution | |
| RS060518S-II | In distribution | |
| LS071638 | In distribution | |
| RS040525 | In distribution | |
| RS060521 | In distribution | |
| RS060721 | In distribution | |
| RS040721S-II | In distribution | |
| RS071118S | In distribution | |
| FS071135-0 | In distribution | |
| RS051118S | In distribution | |
| FS111138 | In distribution | |
| RS050518 | In distribution | |
| RS060725S | In distribution | |
| LS062338 | In distribution | |
| FS061135-0 | In distribution | |
| FS061135 | In distribution | |
| RS050721 | In distribution | |
| LS061638 | In distribution | |
| RS070518 | In distribution | |
| RS060518S | In distribution | |
| RS050525 | In distribution | |
| RS071118 | In distribution | |
| RS040725S | In distribution | |
| RS060718 | In distribution | |
| RS050718S-II | In distribution | |
| FS041125 | In distribution | |
| RS060721S-II | In distribution | |
| RS050725 | In distribution | |
| RS051118 | In distribution | |
| RS051118S-II | In distribution | |
| RS040518S | In distribution | |
| RS060725S-II | In distribution | |
| FS041135 | In distribution | |
| RS060725 | In distribution | |
| RS070718S-II | In distribution | |
| RS050518S-II | In distribution | |
| RS050521 | In distribution | |
| RS040721 | In distribution | |
| RS041118S | In distribution | |
| RS050721S | In distribution | |
| RS050725S-II | In distribution | |
| RS060518 | In distribution | |
| FS051135-0 | In distribution | |
| FS071135 | In distribution | |
| RS060718S-II | In distribution | |
| FS081138 | In distribution | |
| FS080535 | In distribution | |
| FS091138 | In distribution | |
| FS101138 | In distribution | |
| RS060721S | In distribution | |
| RS041118 | In distribution | |
| RS060525 | In distribution | |
| FS070535 | In distribution | |
| RS050718 | In distribution | |
| RS070718S | In distribution | |
| RS070518S | In distribution | |
| FS071138 | In distribution | |
| FS081135 | In distribution | |
| RS070518S-II | In distribution | |
| RS050721S-II | In distribution |
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 |
|---|---|
| K172331 | 2018-03-02 |
| K172099 | 2017-10-05 |
| K123475 | 2014-02-03 |
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.