Hybrid Adapter Products

Covellus is developing many Hybrid Adapter products to be used with .035" Catheter, for example Percutaneous Transluminal Angioplasty balloon catheters, stent delivery systems and other interventional devices.

The inital products will serve as a gateway for Modular Catheter Systems and more sophisticated product applications

  • Adds an extra lumen to enable the use of 2 guidewires, using either rapid exchange or over-the-wire techniques

  • Accessory device designation where 510(k) clearance leverages the Parent Module FDA approval

  • 510(k) requires no clinical data 

2- Wire Adapter

  • Reduced profile eliminates ledge at the distal tip of a .035” Parent Module with smaller guidewire

  • Accessory device designation where 510(k) clearance leverages the Parent Module FDA approval

  • 510(k) requires no clinical data or animal study  

Reducer Adapter

  • Similar to the Reducer Adapter. Reduced profile eliminates ledge at the distal tip of a .035” Parent Module with smaller guidewire, but may also include reinforcement at the tip or lubricious coating to facilitate tracking

  • Accessory device designation where 510(k) clearance leverages the Parent Module FDA approval

  • 510(k) requires no clinical data or animal study  

Crossing Adapter

  • Reduced profile eliminates ledge at the distal tip of a .035” Parent Module with smaller guidewire

  • Accessory device designation where 510(k) clearance leverages the Parent Module FDA approval

  • 510(k) requires no clinical data or animal study  

Scoring Adapter

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