Gore® DrySeal Flex Introducer Sheath
Gore DrySeal Flex Introducer Sheath provides vascular access for inserting endovascular devices while limiting blood loss. The assembly combines a flexible introducer sheath, DrySeal valve,…
Gore DrySeal Flex Introducer Sheath provides vascular access for inserting endovascular devices while limiting blood loss. The assembly combines a flexible introducer sheath, DrySeal valve, locking dilator and syringe.
The sheath has a hydrophilic-coated Pebax outer tube reinforced with flat stainless steel wire and a PTFE liner. A tapered tip assists entry, while an embedded marker band makes the sheath visible under fluoroscopy.
Listed Item
GORE DRYSEAL FLEX Introducer Sheath 33cm 11Fr Hydrophilic Coating
Valve and Dilator
The valve has inner film and outer silicone tubes. Injecting 2.5 mL of saline pressurizes the space between them during preparation. The tapered dilator accepts a 0.035-inch guidewire and locks to the valve; its shaft marker helps confirm the correct sheath-dilator combination.
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 | W. L. Gore & Associates, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K160254 |
| Record published | 2024-12-02 |
| Record revised | 2024-03-20 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Length 33 to 65 cm; catheter gauge 10 to 26 Fr; lumen/inner diameter 4 to 8 mm; outer diameter 4.7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GDSF2065 | In distribution | |
| GDSF2433 | Length 39 cm | In distribution |
| DSF2065 | Length 65 cm | In distribution |
| GDSF1045 | In distribution | |
| GDSF2465 | In distribution | |
| DSF2433 | Catheter Gauge 24 Fr | In distribution |
| GDSF1033 | In distribution | |
| GDSF2033 | In distribution | |
| GDSF1533 | In distribution | |
| GDSF2633 | In distribution | |
| DSF2465 | Length 65 cm | In distribution |
| DSF1265 | Length 65 cm | In distribution |
| DSF1245 | Lumen/Inner Diameter 4 mm | In distribution |
| GDSF1245 | In distribution | |
| GDSF1233 | In distribution | |
| GDSF2265 | In distribution | |
| DSF1833 | Length 33 cm | In distribution |
| DSF1045 | Length 45 cm | In distribution |
| DSF1133 | Catheter Gauge 11 Fr | In distribution |
| DSF1033 | Catheter Gauge 10 Fr | In distribution |
| DSF2633 | Catheter Gauge 26 Fr | In distribution |
| DSF1233 | Length 33 cm | In distribution |
| DSF2665 | Length 65 cm | In distribution |
| DSF1633 | Catheter Gauge 15 Fr | In distribution |
| DSF2233 | Catheter Gauge 22 Fr | In distribution |
| DSF1865 | Length 65 cm | In distribution |
| GDSF1433 | In distribution | |
| GDSF1465 | In distribution | |
| GDSF1665 | In distribution | |
| DSF1065 | Length 65 cm | In distribution |
| GDSF1133 | In distribution | |
| GDSF1265 | In distribution | |
| DSF1433 | Catheter Gauge 14 Fr | In distribution |
| GDSF2233 | In distribution | |
| GDSF1065 | In distribution | |
| DSF1533 | Length 33 cm | In distribution |
| DSF2265 | Length 65 cm | In distribution |
| GDSF1633 | In distribution | |
| DSF1465 | Length 65 cm | In distribution |
| GDSF2665 | In distribution | |
| GDSF1833 | In distribution | |
| GDSF1865 | In distribution | |
| DSF1665 | Length 65 cm | In distribution |
| DSF2033 | Catheter Gauge 20 Fr | 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 |
|---|---|
| K160254 | 2016-05-12 |
| K121234 | 2012-11-20 |
| K120428 | 2012-04-20 |
| K093791 | 2010-03-22 |
| K082356 | 2008-08-28 |
| K032073 | 2003-08-13 |
| K920998 | 1992-06-03 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| W. L. Gore & Associates, Inc. | 510(k) number | 2019-11-18 | Class II | Labeling Change Control | The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices. | 141 devices | 2020-05-13 |
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.