AuST Steerable Sheath
AuST is a steerable vascular sheath that creates a pathway for diagnostic or therapeutic devices. It supports intracardiac, renal and other peripheral placements and is intended for single…
AuST is a steerable vascular sheath that creates a pathway for diagnostic or therapeutic devices. It supports intracardiac, renal and other peripheral placements and is intended for single use.
The braid-reinforced shaft has a bidirectionally deflectable segment and radiopaque distal tip. A handle controls the deflection, while a hemostasis valve limits air and fluid leakage around the access path.
Listed Item
The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
Ports and Size Options
A three-way stopcock supports flushing and aspiration, and a dilator is part of the access assembly. Inner-diameter options include 8.5F, 10F, 12F and 13.2F. The sheath family accommodates different anatomy and introduced devices; its intended use excludes neural placement.
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 | Centerpoint Systems LLC, United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K240829 |
| Record published | 2024-09-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter working length 44 to 84 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000780-S5074TSS | In distribution | |
| 0-085H-H1774SAN3-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 0-132H-H3565SAN0-SNSP0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| 0-085H-H2244SAN0-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 0-100H-H2274SAN5-SNSP0 | Catheter Inner Diameter, French Size = 10F | In distribution |
| 000780-H2274TSS | In distribution | |
| 0-100H-H1774SAN0-SNST0 | In distribution | |
| 0-132H-H3574SAN5-SNSP0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| 0-120H-H3565SAN0-SNSP0 | Catheter Inner Diameter, French Size = 12F | In distribution |
| 0-085H-H5074SAN0-SNCP0 | In distribution | |
| 0-085H-H1774SAN5-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 0-085H-H2274SAN5-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| M85-MD-001465 | In distribution | |
| 0-120H-S3574SAN0-SNSP0 | In distribution | |
| 0-100H-H2284SAN0-SNSP0 | In distribution | |
| 0-100H-H2274SAN0-SNSP0 | Catheter Inner Diameter, French Size = 10F | In distribution |
| 0-132H-H2274SAN5-SNSP0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| 0-132H-H3584SBN5-SNSP0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| 0-085H-H1774SAN0-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 000780-S2274TSS | In distribution | |
| 0-100P-S5074SAN0-SNST0 | In distribution | |
| 0-132H-H5084SBN0-SNSP0 | In distribution | |
| 0-100H-H1774SAN0-SNSP0 | Catheter Inner Diameter, French Size = 10F | In distribution |
| 0-085H-H1784SAN0-SNSP0 | In distribution | |
| 0-100H-H5074SAN0-SNST0 | In distribution | |
| 0-085H-H3574SAN5-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 0-120H-H2274SAN5-SNSP0 | Catheter Inner Diameter, French Size = 12F | In distribution |
| 0-085H-H5084SAN0-SNSP0 | In distribution | |
| 0-132H-H3544SAN0-SNSP0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| 0-085H-S1774SAN0-SNST0 | In distribution | |
| 0-100H-H2274SAN0-SNST0 | In distribution | |
| 0-132H-H3574SAN0-SNSP0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| 0-085H-S2274SAN0-SNST0 | In distribution | |
| 0-085H-H3544SAN0-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 0-100H-H5074SAN0-SNSP0 | Catheter Inner Diameter, French Size = 10F | In distribution |
| 0-100H-H3574SAN5-SNSP0 | Catheter Inner Diameter, French Size = 10F | In distribution |
| 0-100H-H1774SAN3-SNSP0 | Catheter Inner Diameter, French Size = 10F | In distribution |
| 0-132H-H3574SAN0-SNST0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| 000786-S5074TSS | In distribution | |
| 0-100H-H1784SAN0-SNSP0 | In distribution | |
| 0-085H-H2274SAN0-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 0-132H-H5044SAN0-SNSP0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| 0-085H-H5074SAN0-SNST0 | In distribution | |
| M85-MD-001467 | In distribution | |
| 000780-S1774TSS | In distribution | |
| 0-085H-H1774SAN0-SNST0 | In distribution | |
| 000780-H5074TSS | In distribution | |
| 000792-S1774TSS | In distribution | |
| 0-100H-H5084SAN0-SNSP0 | In distribution | |
| 0-085H-H2284SAN0-SNSP0 | In distribution | |
| 0-120H-H1774SAN5-SNSP0 | Catheter Inner Diameter, French Size = 12.0F | In distribution |
| 0-132H-H5074SAN0-SNSP0 | Catheter Inner Diameter, French Size = 13.2F | In distribution |
| M85-MD-001466 | In distribution | |
| 0-085H-S5074SAN0-SNST0 | In distribution | |
| 0-085H-H1744SAN0-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 0-085H-H5074SAN0-SNSP0 | Catheter Inner Diameter, French Size = 8.5F | In distribution |
| 0-120H-H3574SAN5-SNSP0 | Catheter Inner Diameter, French Size = 12F | In distribution |
| 000792-S2274TSS | In distribution | |
| 0-120H-H3584SBN5-SNSP0 | Catheter Inner Diameter, French Size = 12F | In distribution |
| 0-132H-S3574SAN0-SNST0 | 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 |
|---|---|
| K261492 | 2026-06-05 |
| K260942 | 2026-04-07 |
| K260163 | 2026-02-19 |
| K251051 | 2025-04-30 |
| K242106 | 2024-10-04 |
| K240829 | 2024-05-01 |
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.