Super Sheath R/O
Super Sheath provides an entry route for diagnostic or interventional devices into peripheral and coronary blood vessels. A dilator supports placement of the introducer sheath over a…
Super Sheath provides an entry route for diagnostic or interventional devices into peripheral and coronary blood vessels. A dilator supports placement of the introducer sheath over a guidewire. After positioning, the dilator is removed so that compatible devices can pass through the sheath.
The sheath has a hub with a hemostatic valve to limit blood leakage. A side tube with a three-way stopcock allows fluid or medication administration and blood sampling. The sheath shaft and hub use ETFE and polyamide materials.
Supply and Size Options
The system is supplied sterile following ethylene oxide sterilization for one procedure. Available configurations include 4 to 9 French sheath diameters and 7 to 25 cm lengths; the selected dilator must match the guidewire diameter.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Togo Medikit Co., Ltd., Japan |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K200379 |
| Record published | 2025-03-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store at room temperature, in a dry, dark place. |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BT40Z11PPWX35 | In distribution | |
| BT90Z07TPWX38 | In distribution | |
| BT70Z25PPWX38 | In distribution | |
| BT70Z11PPWX38 | In distribution | |
| BT60Z25PPWX38 | In distribution | |
| BT50Z11PPWX38 | In distribution | |
| BT90Z25TPWX38 | In distribution | |
| BT70Z07PPWX38 | In distribution | |
| BT90Z11TPWX38 | In distribution | |
| BT50Z25PPWX38 | In distribution | |
| BT60Z07PPWX38 | In distribution | |
| BT40Z25PPWX35 | In distribution | |
| BT80Z07PPWX38 | In distribution | |
| BT60Z11PPWX38 | In distribution | |
| BT80Z11PPWX38 | In distribution | |
| BT50Z07PPWX38 | In distribution | |
| BT80Z25PPWX38 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prelude® | Merit Medical Systems, Inc. | 323 |
| Prelude PRO™ | Merit Medical Systems, Inc. | 132 |
| Cook | Cook Incorporated | 125 |
| Avanti | Cordis Corp. | 81 |
| Dilator, Vessel, For Percutaneous Catheterization | B. Braun Interventional Systems, Inc. | 59 |
| Merit MAK™ | Merit Medical Systems, Inc. | 49 |
| Prelude ACT™ | Merit Medical Systems, Inc. | 38 |
| AngioDynamics | Navilyst Medical, Inc. | 38 |
| Super Sheath | Togo Medikit Co., Ltd. | 31 |
| Avanti | Cordis US Corp. | 29 |
| Mini Stick MAX | AngioDynamics, Inc. | 28 |
| OneStic Micro-Access Introducer | Argon Medical Devices, Inc. | 27 |
Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200379 | 2020-03-19 |
| K141070 | 2015-01-15 |
| K052557 | 2006-01-17 |
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.