Brilliant
The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide…
The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction 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 or the intravascular catheter and contains marking that are visible under fluoroscopy, which can determine the length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The hydrophilic coated 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. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
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 | 2026-04-15 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS041618 | In distribution | |
| RSC062421 | In distribution | |
| RSC071125 | In distribution | |
| CS061125 | In distribution | |
| RSC060725 | In distribution | |
| CS052425 | In distribution | |
| ACS062435 | In distribution | |
| ACS050721 | In distribution | |
| RSC071121 | In distribution | |
| CS051125 | In distribution | |
| RSC040725 | In distribution | |
| RSC060721A | In distribution | |
| CS071121 | In distribution | |
| ACS051121-II | In distribution | |
| CS071621 | In distribution | |
| CS050718 | In distribution | |
| CS061618 | In distribution | |
| ACS061635 | In distribution | |
| ACS041121-II | In distribution | |
| RSC071621 | In distribution | |
| RSC041125 | In distribution | |
| RSC052425 | In distribution | |
| CS062418 | In distribution | |
| ACS052421 | In distribution | |
| ACS062421 | In distribution | |
| ACS062421-II | In distribution | |
| RSC071621A | In distribution | |
| RSC042421 | In distribution | |
| RSC062425 | In distribution | |
| RSC041625 | In distribution | |
| RSC070721 | In distribution | |
| CS060718 | In distribution | |
| CS040718 | In distribution | |
| CS061118 | In distribution | |
| CS061121 | In distribution | |
| CS071125 | In distribution | |
| CS062425 | In distribution | |
| CS042421 | In distribution | |
| CS041625 | In distribution | |
| CS041125 | In distribution | |
| CS052418 | In distribution | |
| ACS052421-II | In distribution | |
| CS051618 | In distribution | |
| CS051625 | In distribution | |
| ACS060721 | In distribution | |
| ACS040721 | In distribution | |
| ACS071635 | In distribution | |
| CS060721 | In distribution | |
| CS042425 | In distribution | |
| RSC070725 | In distribution | |
| CS052421 | In distribution | |
| RSC050721 | In distribution | |
| ACS060735 | In distribution | |
| RSC061121 | In distribution | |
| CS062421 | In distribution | |
| RSC042425 | In distribution | |
| RSC041621 | In distribution | |
| RSC051621 | In distribution | |
| RSC040721A | In distribution | |
| RSC042421A | In distribution | |
| RSC051121 | In distribution | |
| ACS071121-II | In distribution | |
| CS051621 | In distribution | |
| RSC072425 | In distribution | |
| CS071118 | In distribution | |
| CS070718 | In distribution | |
| CS072418 | In distribution | |
| RSC050725 | In distribution | |
| ACS071135 | In distribution | |
| ACS040721-II | In distribution | |
| RSC052421 | In distribution | |
| RSC051625 | In distribution | |
| CS072425 | In distribution | |
| RSC070721A | In distribution | |
| RSC071625 | In distribution | |
| CS042418 | In distribution | |
| CS040721 | In distribution | |
| CS051121 | In distribution | |
| CS041118 | In distribution | |
| RSC041121A | In distribution | |
| RSC050721A | In distribution | |
| RSC062421A | In distribution | |
| RSC052421A | In distribution | |
| RSC041621A | In distribution | |
| RSC071121A | In distribution | |
| RSC040721 | In distribution | |
| RSC061621A | In distribution | |
| ACS042421-II | In distribution | |
| CS050721 | In distribution | |
| RSC061121A | In distribution | |
| CS041121 | In distribution | |
| CS060725 | In distribution | |
| ACS042421 | In distribution | |
| CS061621 | In distribution | |
| CS040725 | In distribution | |
| ACS060721-II | In distribution | |
| CS041621 | In distribution | |
| RSC060721 | In distribution | |
| CS070721 | In distribution | |
| RSC061125 | In distribution | |
| ACS072435 | In distribution | |
| ACS070721-II | In distribution | |
| CS071618 | In distribution | |
| ACS061135 | In distribution | |
| ACS050721-II | In distribution | |
| RSC051125 | In distribution | |
| RSC072421 | In distribution | |
| RSC051621A | In distribution | |
| CS050725 | In distribution | |
| RSC061625 | In distribution | |
| CS051118 | In distribution | |
| RSC061621 | In distribution | |
| ACS061121-II | In distribution | |
| CS071625 | In distribution | |
| CS072421 | In distribution | |
| CS061625 | In distribution | |
| RSC041121 | In distribution | |
| ACS070735 | In distribution | |
| ACS072421-II | In distribution | |
| CS070725 | In distribution | |
| RSC051121A | In distribution | |
| RSC072421A | 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 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
| Tearaway Introducer Set | Galt Medical Corp. | 96 |
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.