Integer - Guiding Catheters & Sheaths
From Catheters
We provide a full range of guiding catheters and sheaths for peripheral vascular applications that supports every phase of the product life cycle. Design and development of guiding catheters and sheaths for peripheral vascular applications. Transfer of products and processes from one site to another to support product-line transfer, line duplication, low-cost manufacturing, and prototype-to-production migration. Manufacture of completed guiding catheters and sheaths as well as custom medical device components, including multi-layer, multi-durometer shafts with braid, PTFE liner, proximal visual markers and embedded marker bands. Design for manufacturability (DFM) to assure that final products can be repeatedly manufactured while meeting quality, reliability, and performance requirements.
Details
Clinical and regulatory expertise; understanding of emerging clinical trends through our physician advisory board; preclinical product evaluation; validated mechanical and electrical test methods; and medical device registration, reporting, and vigilance.
Materials & Processes
With comprehensive manufacturing capabilities, we develop guiding catheters and sheaths in a wide range of models and configurations. Our technical experts ensure the highest-quality materials are matched to the precise design specifications and requirements of every component and device we manufacture.
We maintain ISO 13485 certification across our facilities, as well as quality and process management systems that meet the highest standards set by the United States Food and Drug Administration, the European Community, and other international regulatory authorities. Our technical experts ensure design for manufacturability to decrease development time, minimize costs, and achieve speed to market.
Molding
Master Unit Die (MUD), single- or dual-cavity and insert molding
Extrusion
Low- & high-melt polymers, single-lumen, multi-lumen, bump tubing, co-extrusion, wire enforced, braided and liners
Wire Drawing & Dielectric Coating
Substrates: Clad wire, MP35N, stainless steel, platinum and polymer coatings PTFE, ETFE, polyimide, polyethylene and nylon
Reinforcement Shafts
Computer modeling (Virtual Tube Modeling™) to maximize performance, braided, coiled, lamination, multi-durometer polymers, radiopaque-loaded polymers, reflowed shafts, pressure extrusion, thin-walled tight tolerance and lubricous liners
Support Members & Machined Components
Coils, marker bands, laser/machined-metal spines and ground cores, CNC machining, laser cutting, laser hole drilling, EDM and precious metals (platinum, gold & other alloys)
Assembly
Hub molding, reflow, tipping and handle attachment
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