Super Sheath
Super Sheath provides an access pathway for introducing diagnostic or interventional devices into peripheral or coronary vessels. The system includes an introducer sheath and tapered…
Super Sheath provides an access pathway for introducing diagnostic or interventional devices into peripheral or coronary vessels. The system includes an introducer sheath and tapered dilator, with a guidewire supplied in its own case. The dilator supports entry of the sheath and is removed once vascular access is established.
The sheath hub contains a hemostatic valve to limit blood leakage and a side tube with a three-way stopcock. The extension allows fluid or medication administration and blood sampling. Available introducer diameters range from 4 to 9 Fr, with lengths from 7 to 25 cm.
Guidewire and Configuration Options
The dilator locks into the sheath by rotation. The 4 Fr dilator accepts a 0.035-inch guidewire; 5 to 9 Fr options accept 0.035 or 0.038 inches. Some sheaths have a radiopaque marker near the distal tip. The system is supplied sterile for one procedure.
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 |
|---|---|---|
| BT60Z11PGW038 | In distribution | |
| BT60Z25PPW038 | In distribution | |
| BT70Z11PPW038 | In distribution | |
| BT40Z07PGW035 | In distribution | |
| BT50Z07PGW035 | In distribution | |
| BT90Z11TGW035 | In distribution | |
| BT60Z25PPW035 | In distribution | |
| BT50Z25PPW038 | In distribution | |
| BT60Z07PGW038 | In distribution | |
| BT50Z11PGW035 | In distribution | |
| BT90Z11TGW038 | In distribution | |
| BT80Z25PPW038 | In distribution | |
| BT70Z11PGW038 | In distribution | |
| BT80Z11PGW035 | In distribution | |
| BT50Z11PPW038 | In distribution | |
| BT70Z25PPW035 | In distribution | |
| BT40Z11PPW035 | In distribution | |
| BT90Z25TPW038 | In distribution | |
| BT60Z11PPW038 | In distribution | |
| BT70Z25PPW038 | In distribution | |
| BT70Z11PGW035 | In distribution | |
| BT60Z07PGW035 | In distribution | |
| BT90Z11TPW038 | In distribution | |
| BT40Z11PGW035 | In distribution | |
| BT70Z07PGW035 | In distribution | |
| BT60Z11PGW035 | In distribution | |
| BT80Z11PGW038 | In distribution | |
| BT50Z11PGW038 | In distribution | |
| BT80Z25PPW035 | In distribution | |
| BT80Z11PPW038 | In distribution | |
| BT50Z25PPW035 | 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 |
| Avanti | Cordis US Corp. | 29 |
| Mini Stick MAX | AngioDynamics, Inc. | 28 |
| OneStic Micro-Access Introducer | Argon Medical Devices, Inc. | 27 |
| Medcomp Vessel Dilatormedcomp Vessel Dilator | Medical Components Inc | 26 |
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.