Breeze Digital Inflation Device

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K953676 ↗

FDA Product Code

MAV

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Catheter, Arterial Line

  Class II

  FDA 510(k) K790083 Active Cleared 25 Jan 1979

• Stopcocks, Manifolds Open recall

  Class II

  FDA 510(k) K782095 Active Cleared 23 Jan 1979

• High Pressure Contrast Injection Line

  Class II

  FDA 510(k) K822100 Active Cleared 24 Aug 1982

• Arterial Extension Set

  Class II

  FDA 510(k) K790082 Active Cleared 25 Jan 1979

• Perceptor Compensator Morse Manifold

  Class II

  FDA 510(k) K951722 Active Cleared 25 Mar 1996

• Continuous Flush Device

  Class II

  FDA 510(k) K813549 Active Cleared 12 Jan 1982

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• Is the Breeze Digital Inflation Device intended for single-use or can it be reused in multiple procedures?

  The Breeze Digital Inflation Device is explicitly described as a reusable medical instrument. Since it is designed for use in sterile environments like catheterization labs and operating rooms, it must be properly cleaned, disinfected, and sterilized between uses to maintain safety and performance standards.

• What types of cardiovascular procedures is the Breeze Digital Inflation Device primarily used for?

  The device is specifically designed for precise inflation and deflation of angioplasty balloons during interventional radiology and cardiology procedures. This includes applications where controlled pressure is critical, such as percutaneous coronary interventions (PCI) or peripheral angioplasty.

• How is the Breeze Digital Inflation Device regulated, and what does its FDA clearance status mean for buyers?

  The Breeze Digital Inflation Device holds an FDA 510(k) clearance (K953676) under Class II regulatory standards, granted in 1996. This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA requirements for safety and effectiveness. Buyers can rely on this clearance as evidence of regulatory compliance for use in sterile environments like catheterization labs.

• Does the Breeze Digital Inflation Device include any software-dependent features, or is it purely hardware-based?

  The device features a non-software-driven solid-state digital gauge, meaning its pressure measurement functionality relies entirely on hardware components rather than software. This design ensures reliability and eliminates potential software-related malfunctions during critical procedures.

• What storage or handling considerations should be taken into account for the Breeze Digital Inflation Device?

  While the device is reusable, no specific storage instructions (e.g., temperature, humidity, or shelf life) are provided in the available data. However, since it is intended for sterile environments, it should be stored in a clean, dry location when not in use and undergo proper cleaning, disinfection, and sterilization protocols between procedures to maintain its integrity and performance.