Rotational Response

A customer-defined number of revolutions is applied to the proximal end of a device with a customer defined step. At each step, the corresponding rotation at the distal end is measured by direct reading on the distal measurement system and then recorded. The tests can be performed in straight path or in a predefined arterial model.

 

 

Test Procedure

Additionally for Atherectomy devices, this provides confirmation that the device does not rotate unexpectedly upon activation.

Measured Parameters

Rotation at the distal end in response to rotation at Proximal end.

Service Levels

Applicable Standards

  • FDA-16013
    FDA Guidance: Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions

Related Tests

OLE0812


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