PressureWire Aeris Agile Tip; PressureWire Aeris Agile Tip 300

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

510(k) Number

K133587 ↗

FDA Product Code

DRG

Models / Variants

Pressurewire Aeris Agile Tip

Pressurewire Aeris Agile Tip 300

Device Class

Class II

Regulation

21 CFR Part 870.2910

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pressurewire; Certus, Certus 300, Aeris, Aeris 300

  Class II

  FDA 510(k) K131452 Active Cleared 5 Sep 2013

• Femostop Plys, Femostop Hd, Femostop Compression Arch; Femostop II Plus Set; Femostop II Plus Arch, Bilateral Adapter; F

  Class II

  FDA 510(k) K110193 Active Cleared 24 Feb 2011

• Ao USB Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, Pw USB Receiver

  Class II

  FDA 510(k) K111854 Active Cleared 21 Oct 2011

• Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300

  Class II

  FDA 510(k) K140466 Active Cleared 13 Nov 2014

• What is the PressureWire Aeris Agile Tip used for?

  The PressureWire Aeris Agile Tip is a wireless pressure guidewire specifically designed for fractional flow reserve (FFR) measurement during cardiovascular procedures. Its symmetrical tip design provides exceptional agility and torque response in sharp bends, allowing physicians to perform reliable FFR measurements efficiently.

• Is the PressureWire Aeris Agile Tip reusable or MRI safe?

  The PressureWire Aeris Agile Tip is supplied as a single-use product and is not MRI safe. It is designed for single use only to ensure optimal performance and patient safety, and should not be used in MRI environments as it may pose safety risks.

• What regulatory approvals does the PressureWire Aeris Agile Tip have?

  The PressureWire Aeris Agile Tip has received FDA 510(k) clearance with the product code DRG. It is manufactured by St. Jude Medical Systems AB and is regulated under 870.2910. The device is classified as substantially equivalent to predicate devices for cardiovascular procedures.

• What are the key features of the PressureWire Aeris Agile Tip?

  The key feature of the PressureWire Aeris Agile Tip is its proprietary symmetrical tip design that provides exceptional agility and torque response in sharp bends. This allows physicians to navigate challenging anatomical structures more easily while performing accurate fractional flow reserve measurements during cardiovascular procedures.