DuraSheath Introducer Sheath System
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
13manufacturers in China registered for this device type
31catalogue numbers in this listing
8510(k) clearances naming this product code
1recall
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 | Contract Medical International GmbH, Germany |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2019-02-12 |
| Record revised | 2024-03-20 (version 4) |
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 |
| Storage | Special storage condition: Keep away from direct sunlight; Special storage condition: Keep Dry |
| Packaging | Packer of 5, corrugate, corrugate / shipper, corrugate/shipper, paker of 5 |
| Sizes | Length 15 to 90 cm; lumen/inner diameter 1.6 to 2.88 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6F, 90cm, straigth, firm | Length 90 cm | In distribution |
| 8F, 90cm, straight, firm | Length 90 cm | In distribution |
| 7F, 60cm, straight, firm | Length 60 cm | In distribution |
| 8F, 45cm, straigth | Lumen/Inner Diameter 2.88 mm | In distribution |
| 5F, 15cm, straigth | Lumen/Inner Diameter 1.92 mm | In distribution |
| 6F, 45cm, straigth | Lumen/Inner Diameter 2.25 mm | In distribution |
| 6F, 45cm, straigth, firm | Length 45 cm | In distribution |
| 8F, 45cm, straigth, firm | Length 45 cm | In distribution |
| 5F, 60cm, straigth | Length 60 cm | In distribution |
| 5F, 60cm, straight, firm | Length 60 cm | In distribution |
| 6F, 90cm, straigth | Length 90 cm | In distribution |
| 5F, 90cm, straigth | Length 90 cm | In distribution |
| 5F, 45cm, straight, firm | Length 45 cm | In distribution |
| 8F, 90cm, straigth | Lumen/Inner Diameter 2.88 mm | In distribution |
| 4F, 45cm, straigth | Lumen/Inner Diameter 1.60 mm | In distribution |
| 5F, 45cm, straigth | Length 45 cm | In distribution |
| 7F, 90cm, straight, firm | Length 90 cm | In distribution |
| 4F, 15cm, straigth | Length 15 cm | In distribution |
| 6F, 15cm, straight, firm | Length 15 cm | In distribution |
| 8F, 60cm, straigth | Length 60 cm | In distribution |
| 7F, 45cm, straigth, firm | Length 45 cm | In distribution |
| 6F, 60cm, straigth | Length 60 cm | In distribution |
| 4F, 60cm, straigth | Length 60 cm | In distribution |
| 6F, 60cm, straight, firm | Length 60 cm | In distribution |
| 7F, 45cm, straigth | Lumen/Inner Diameter 2.55 mm | In distribution |
| 8F, 60cm, straight, firm | Length 60 cm | In distribution |
| 7F, 90cm, straigth | Lumen/Inner Diameter 2.55 mm | In distribution |
| 5F, 90cm, straight, firm | Length 90 cm | In distribution |
| 6F, 15cm, straigth | Lumen/Inner Diameter 2.25 mm | In distribution |
| 7F, 60cm, straigth | Lumen/Inner Diameter 2.55 mm | In distribution |
| 4F, 90cm, straigth | Length 90 cm | 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 |
|---|---|
| K250439 | 2025-03-16 |
| K240957 | 2024-08-14 |
| K221914 | 2022-07-29 |
| K203179 | 2020-11-20 |
| K181463 | 2018-12-13 |
| K153197 | 2016-01-11 |
| K142357 | 2015-06-25 |
| K100799 | 2011-02-25 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-07-30 | Class II | Under Investigation by firm | Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version. | 2500 |
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.