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The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.

The PLUS 30 PRIORITY PACKTM:

INDEFLATOR PLUS 30TM Inflation Device- See description above.

PLUS 30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)

INDEFLATOR PLUS 30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.

The PLUS 30 PRIORITY PACK™ is comprised of the INDEFLATOR PLUS 30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve.

This 510(k) summary is for a medical device (Inflation Device) and does not contain information related to an AI/ML powered device. Therefore, it is not possible to extract the requested information about acceptance criteria, study design, and ground truth as these concepts are not applicable to the provided text.

The document describes the device, its intended use, and claims substantial equivalence to previously cleared devices. It does not present any performance studies or acceptance criteria in the context of an AI/ML algorithm.

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