Pruitt-Inahara Carotid Shunt 400-40-8F/INAHARA-PRUITT Carotid Shunt 500-50-8F

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K960715 ↗

FDA Product Code

MJN

Device Class

Class II

Regulation

21 CFR Part 870.4450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Pruitt Embolectomy/Irrigation Catheter (Modified)

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• Modified Pruitt Irrigation & Occlusion Catheter Open recall

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• Robicsek–Pruitt Aortic Balloon Occlusion Kit

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See all devices from Ideas For Medicine, Inc. →

• What are the primary uses for the Pruitt-Inahara Carotid Shunt in surgical procedures?

  The Pruitt-Inahara Carotid Shunt (models 400-40-8F and 500-50-8F) is designed for temporary arterial access or bypass during carotid artery procedures. It helps control blood flow while minimizing trauma to the vessel wall, making it suitable for cases where smaller arteries require precise intervention that larger catheters cannot accommodate.

• Are these shunts intended for single-use or can they be reused?

  The Pruitt-Inahara Carotid Shunt is explicitly supplied as a single-use device. This design ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks.

• What sizes are available for the Pruitt-Inahara Carotid Shunt, and how do they differ?

  The device comes in two sizes: 400-40-8F and 500-50-8F. Both are tailored for smaller arteries where traditional 9 French shunts are impractical. The T-port feature in both models allows for patency confirmation and back-bleeding, ensuring proper function during use.

• How is the regulatory status of this device determined?

  The Pruitt-Inahara Carotid Shunt holds FDA 510(k) clearance (K960715) and is classified as a Class II medical device under FDA regulation 870.4450. This classification reflects its intended use as an intravascular, temporary occluding catheter for carotid artery procedures, with a history of substantial equivalence to prior devices.

• What should clinicians consider when storing these shunts before use?

  While the provided data does not specify storage conditions, as a single-use, sterile medical device, these shunts should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging integrity must be maintained until immediate use to preserve sterility and functionality.