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

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:

Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.