SS085075S: Stryker Steerable Sheath Introducer 8.5F x 75cm, Small Curl

Expired » Stryker Neurovascular » Steerable Sheath

Stryker 8.5F Steerable Sheath Introducer, Small Curl

The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

Product Code: SS085075S

• Small Curl
• Introducer: 8.5F (2.9mm) ID / 12F (4.1mm) OD
• Usable Length: 75cm
• Lumen Length: 91cm
• Dilator: 8.5F (3.0mm) OD / 93cm Usable Length
• Guidewire: 0.032" x 0.82mm) x 180cm J-Tip
• Max Guidewire: 0.032" (0.82mm)
• Needle Compatibility: 98cm

Sterilization

• Device Packaged as Sterile: Yes
• Requires Sterilization Prior to Use: No 
• Single-Use
• Disposable

Additional Details

• Company Name: Freudenberg Medical, LLC
• FDA Product Code: DYB
• FDA Product Code Name: Introducer, Catheter
• GMDN Term Code: 17846
• GMDN Term Name: Vascular guide-catheter, single-use
• GMDN Term Definition: A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
• GMDN Term Code: 38128
• GMDN Term Name: Vascular dilator, single-use
• GMDN Term Definition: A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Stryker Neurovascular is a global leader in stroke care and neurointervention, offering a comprehensive portfolio of devices for the treatment of ischemic and hemorrhagic stroke. Their product lines include the Trevo Retriever for mechanical thrombectomy, the AXS Infinity and AXS Catalyst distal access catheters, and the Target coil family for aneurysm embolization. Stryker also offers the Neuroform Atlas and LVIS stents for stent-assisted coiling, as well as the Surpass Evolve flow diverter for treating large or wide-neck intracranial aneurysms. With a focus on rapid innovation, clinical outcomes, and stroke workflow optimization, Stryker Neurovascular continues to shape the future of minimally invasive neurosurgery.