Kantron 40 CC PDLIAB Adaptation

No FDA recalls on record, checked 6 Oct 2026.

Full name

Adaptation of Kantron 40 Cc. Pdliab

510(k) Number

K820166 ↗

FDA Product Code

DSP

Device Class

Class II

Regulation

21 CFR Part 870.3535

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Kontron Instruments, Inc. →

• What is the primary clinical purpose of the Kantron 40 CC PDLIAB Adaptation, and in which settings is it typically used?

  The Kantron 40 CC PDLIAB Adaptation is designed for temporary mechanical circulatory support by inflating and deflating an intra-aortic balloon to improve coronary perfusion, reduce myocardial oxygen demand, and assist cardiac function during critical cardiovascular procedures or conditions. It is intended for use in controlled clinical settings such as cardiac catheterization labs or intensive care units where real-time monitoring and sterile handling are essential.

• Is this device intended for single-use or repeated use, and why does that matter?

  This device is explicitly intended for single-use only in sterile settings. This design ensures patient safety by preventing cross-contamination and maintaining device integrity, which is critical for procedures requiring precise mechanical circulatory support. Reuse could compromise sterility and performance, risking complications during cardiac interventions.

• What storage instructions should be followed to maintain the device’s performance and sterility?

  The device must be stored according to the manufacturer’s instructions to preserve both performance and sterility. Since it is single-use and sterile upon packaging, improper storage—such as exposure to moisture, extreme temperatures, or physical damage—could compromise its functionality or integrity before use. Always adhere to the provided guidelines to ensure reliability in critical procedures.

• Can this device be used in an MRI environment, and if not, what alternatives should clinicians consider?

  No, the Kantron 40 CC PDLIAB Adaptation is not MRI-compatible. Clinicians should avoid using it in proximity to MRI machines, as the magnetic fields could interfere with the device’s operation or pose safety risks. For patients requiring both circulatory support and MRI imaging, alternative non-MRI-compatible devices or procedural adjustments may be necessary.

• How is the regulatory pathway for this device structured, and what does the FDA clearance indicate?

  This device holds FDA 510(k) clearance (K820166) under regulation 870.3535, classifying it as a Class II medical device. The clearance was granted through a traditional 510(k) review by the FDA’s Cardiovascular (CV) advisory committee, confirming it is *substantially equivalent* to a legally marketed predicate device. This pathway ensures it meets safety and effectiveness standards for temporary mechanical circulatory support in approved clinical applications.