Home > Products > Finished Balloon Catheters – 510(k) Approved
TechDevice has completed all of the front end work for a variety of ready to go balloon catheters – design, development and 510(k) submissions with clearance. This is an ideal service for OEM’s who are looking for total outsourcing solutions.
Currently, TechDevice has FDA approval for Latex Occlusion Balloons for temporary Intravascular Occlusion.
Hybrid Custom Program Minimizes 510(k) Clearance Time and Cost
Another option to consider is to leverage our existing 510(k) clearance to expedite a faster turnaround and at far less the cost than a total custom balloon catheter. TechDevice can submit a special 510(k) as an addendum to one of our existing 510(k)'s, and get clearance in as little time as 30-60 days.
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