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TechDevice prides itself on its ability to custom manufacture to exact specifications, pre-approved guidewires.  This includes any shape or size, using any materials. However, as needed, TechDevice will provide assistance in securing 510(k) clearance for our OEM customers.

Hybrid Custom Program Minimizes 510(k) Clearance Time and Cost
Another option to consider is to leverage our existing products with 510(k) clearance to expedite a faster turnaround and at far less the cost than a total custom guidewire.  For example, your need is a nitinol core rather than stainless, or a polyurethane jacket instead of PTFE. TechDevice can submit a special 510(k) as an addendum to one of our existing 510(k)’s and can get clearance in as little time as 30-60 days and less expensive than starting out new.