Biotronik Fortress Introducer Sheath System
Fortress Introducer Sheath System provides vascular access for guidewires, catheters and other devices. It combines a sheath with a hemostasis valve, side port and tapered dilator for…
Fortress Introducer Sheath System provides vascular access for guidewires, catheters and other devices. It combines a sheath with a hemostasis valve, side port and tapered dilator for insertion.
The valve seals around the inserted device to limit blood leakage. The side port and three-way stopcock support flushing, and a distal radiopaque marker helps identify sheath position.
Listed Item
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
Sheath Configurations
The 5 and 6 Fr configurations use thermoplastic tubing reinforced by a stainless-steel coil and a hydrophobic silicone coating over the distal 30 cm. These configurations have one or two dilators depending on length. The system is supplied sterile for single-patient use.
13manufacturers in China registered for this device type
46catalogue 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 |
| 510(k) | K153197 |
| Record published | 2024-06-24 |
| Record revised | 2024-03-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry; Special storage condition: Keep away from sunlight; Storage environment temperature 10 to 40 °C |
| Packaging | Packer of 5, packer / inner box of 5, packer/inner box of 5, packer / inner boc of 5 |
| Sizes | Length 45 to 100 cm; lumen/inner diameter 1.62 to 2.88 mm; lumen/inner diameter 1.62 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5F; 100 cm; straight | Length 100 cm | In distribution |
| 7F; 45 cm; crossover | Length 45 cm | In distribution |
| 4F; 90 cm; straight | Lumen/Inner Diameter 1.62 mm | In distribution |
| 100 cm, 4F Straight | Lumen/Inner Diameter 1.62 mm | In distribution |
| 5F; 45 cm; crossover | Length 45 cm | In distribution |
| 65 cm, 5F Straight | Lumen/Inner Diameter 1.95 mm | In distribution |
| 7F; 65 cm; straight | Length 65 cm | In distribution |
| 7F, 90cm, straight | Length 90 cm | In distribution |
| 8F, 90cm, straight | Length 90 cm | In distribution |
| 4F; 65 cm; straight | Lumen/Inner Diameter 1.62 mm | In distribution |
| 7F, 65cm, straight | Length 65 cm | In distribution |
| 7F; 45 cm; straight | Length 45 cm | In distribution |
| 4F; 45 cm; crossover | Length 45 cm | In distribution |
| 45 cm, 5F Straight | Length 45 cm | In distribution |
| 8F; 65 cm; straight | Length 65 cm | In distribution |
| 6F; 45 cm; straight | Length 45 cm | In distribution |
| 45 cm, 4F Crossover | Lumen/Inner Diameter 1.62 mm | In distribution |
| 6F; 45 cm; crossover | Length 45 cm | In distribution |
| 65 cm, 4F Straight | Length 65 cm | In distribution |
| 65 cm, 6F Straight | Lumen/Inner Diameter 2.20 mm | In distribution |
| 6F; 65 cm; straight | Length 65 cm | In distribution |
| 8F; 45 cm; straight | Length 45 cm | In distribution |
| 5F; 90 cm; straight | Length 90 cm | In distribution |
| 7F; 90 cm; straight | Length 90 cm | In distribution |
| 7F, 45cm, Crossover | Length 45 cm | In distribution |
| 8F, 45cm, Crossover | Length 45 cm | In distribution |
| 45 cm, 6F Crossover | Lumen/Inner Diameter 2.28 mm | In distribution |
| 90 cm, 4F Straight | Lumen/Inner Diameter 1.62 mm | In distribution |
| 5F; 65 cm; straight | Length 65 cm | In distribution |
| 90 cm, 5F Straight | Lumen/Inner Diameter 1.95 mm | In distribution |
| 8F, 65cm, straight | Length 65 cm | In distribution |
| 8F; 90 cm; straight | Length 90 cm | In distribution |
| 4F; 100 cm; straight | Length 100 cm | In distribution |
| 5F; 45 cm; straight | Length 45 cm | In distribution |
| 45 cm, 6F Straight | Lumen/Inner Diameter 2.28 mm | In distribution |
| 4F; 45 cm; straight | Length 45 cm | In distribution |
| 100 cm, 5F Straight | Lumen/Inner Diameter 1.95 mm | In distribution |
| 7F, 45cm, Straight | Length 45 cm | In distribution |
| 8F, 45cm, Straight | Length 45 cm | In distribution |
| 45 cm, 4F Straight | Lumen/Inner Diameter 1.62 mm | In distribution |
| 8F; 45 cm; crossover | Length 45 cm | In distribution |
| 6F; 100 cm; straight | Length 100 cm | In distribution |
| 100 cm, 6F Straight | Lumen/Inner Diameter 2.28 mm | In distribution |
| 6F; 90 cm; straight | Length 90 cm | In distribution |
| 45 cm, 5F Crossover | Lumen/Inner Diameter 1.95 mm | In distribution |
| 90 cm, 6F Straight | Lumen/Inner Diameter 2.20 mm | 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 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 |
|---|---|---|---|---|---|---|
| Contract Medical International GmbH | 510(k) number | 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.