Home > Products > Finished Guidewires with 510(k) Clearance

TechDevice has completed all of the front end work for a variety of ready to go guidewires – design, prototype development and 510(k) submissions with clearance. This an ideal opportunity for OEM’s to expand their brand name product line without the lead times and costs associated with new product development.

The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature and alimentary track. Specifically, TechDevice guidewires are approved for the following indications:  Gastroenterology/Renal/Urology, Obstetrics/Gynecology, Radiology and Peripheral Vasculature.

Current approvals are for stainless steel guidewires that fall within a matrix of .014” x .038” OD, lengths up to 450 cm., non-coated, spray coated with PTFE or jacketed with PTFE. The matrix covers 100’s of possible configurations to select from.

Most approvals can be customized within the following matrix, however, please contact us for customs falling outside the grid.

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 an approval in as little time as 30-60 days and less expensive than starting out new.