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


ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

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The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.

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