PathBuilder Transseptal Guiding Introducer
PathBuilder Transseptal Guiding Introducer provides a passage for cardiovascular catheters into the left side of the heart through the wall between the atria. The set comprises a sheath,…
PathBuilder Transseptal Guiding Introducer provides a passage for cardiovascular catheters into the left side of the heart through the wall between the atria. The set comprises a sheath, dilator and guidewire.
The sheath and dilator have curved sections for positioning against the atrial septum. The dilator expands the opening during the transseptal procedure, while the guidewire leads the introducer set toward the intended position.
Sheath Features
A distal marker band indicates sheath position. Nearby vent holes reduce cavitation during aspiration and device withdrawal. The proximal sheath has a hemostatic valve for catheter introduction and exchange, plus a sideport with a three-way stopcock for aspiration, infusion, blood sampling or pressure monitoring.
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 | Shanghai Microport EP Medtech Co., Ltd., China |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Manufacturer |
| 510(k) | K212626 |
| Record published | 2024-02-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TSL0638 | In distribution | |
| TSL1818 | In distribution | |
| TSL3818 | In distribution | |
| TSL18185 | In distribution | |
| TSR0638 | In distribution | |
| TSR4818 | In distribution | |
| TSR4638 | In distribution | |
| TSL4818 | In distribution | |
| TSR2818 | In distribution | |
| TSL4818 | In distribution | |
| TSR38185 | In distribution | |
| TSL4638 | In distribution | |
| TSL2818 | In distribution | |
| TSR0818 | In distribution | |
| TSL48185 | In distribution | |
| TSR18185 | In distribution | |
| TSL08185 | In distribution | |
| TSR1638 | In distribution | |
| TSL3638 | In distribution | |
| TSL163 8 | In distribution | |
| TSL36385 | In distribution | |
| TSR0818 | In distribution | |
| TSR36385 | In distribution | |
| TSR3638 | In distribution | |
| TSR46385 | In distribution | |
| TSR2638 | In distribution | |
| TSR28185 | In distribution | |
| TSR06385 | In distribution | |
| TSL48185 | In distribution | |
| TSR16385 | In distribution | |
| TSL2638 | In distribution | |
| TSL38185 | In distribution | |
| TSR3818 | In distribution | |
| TSL16385 | In distribution | |
| TSL46385 | In distribution | |
| TSL0818 | In distribution | |
| TSL26385 | In distribution | |
| TSL48185 | In distribution | |
| TSR4638 | In distribution | |
| TSR08185 | 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 |
|---|---|
| K212626 | 2022-03-23 |
| K211530 | 2022-02-08 |
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.