Distal Access Catheters
Route 92 Medical Access System
Indications for Use
The Route 92 Medical Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
Key Specifications
- Composed of Access Catheter and Delivery Catheter
- Access Catheter: single-lumen, variable stiffness distal portion; proximal stainless-steel control wire
- Delivery Catheter: hubbed, single-lumen variable stiffness catheter
- Both catheters hydrophilically coated
- Access Catheter dimensions: Inner Diameter 0.069 in, Outer Diameter Distal 0.081 in / Proximal 0.087 in, Length 140-153 cm
- Delivery Catheter dimensions: Inner Diameter 0.070 in (minimum), Outer Diameter Distal 0.082 in / Proximal 0.087 in, Length 136 cm
- Materials: polymers and metals commonly used in medical devices, including stainless steel
- Sterile, non-pyrogenic, single-use only
- Coil-reinforced design (equivalent to predicate)
- Biocompatible per ISO 10993-1 (externally communicating with limited blood contact <24 hours)
- Passed performance tests: dimensional verification, Luer integrity, kink resistance, tensile strength, torsion resistance, tip flexibility, burst pressure, flow rates, hydrophilic coating integrity, radiopacity, packaging integrity
Description
The Route 92 Medical Access System is comprised of an Access Catheter and a Delivery Catheter, both single-lumen variable stiffness catheters with hydrophilic coatings. The Access Catheter has a stainless-steel proximal control wire. It is intended for use with compatible guide catheters to facilitate microcatheter insertion and guidance in the neurovascular system. The devices are sterile, non-pyrogenic, and for single use only.