Pediatric Arterial Cannula

• • Terminated Z-2210-2012 FDA Class II ·initiated 29 May 2012 ·on shared 510(k) K023251

  Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K023251 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Safe Mini

  Class II

  FDA 510(k) K980974 Active Cleared 13 Oct 2000

• Safe Maxi Hollow Fiber Oxygenator, Model 016010

  Class II

  FDA 510(k) K013038 Active Cleared 14 Aug 2002

• Safe II

  Class II

  FDA 510(k) K912082 Active Cleared 4 Dec 1991

• Safe Micro

  Class II

  FDA 510(k) K953976 Active Cleared 4 Feb 1997

• Safe Maxi Venous/Cardiotomy Reservoir, Model 016045

  Class II

  FDA 510(k) K022281 Active Cleared 6 Aug 2002

• What is the Pediatric Arterial Cannula designed for?

  The Pediatric Arterial Cannula is specifically designed for arterial access during extracorporeal circulation procedures, such as pediatric cardiac surgeries requiring cardiopulmonary bypass. Its tapered, wire-reinforced PVC body and open beveled distal tip are engineered to facilitate smooth insertion and secure positioning within small-diameter pediatric arteries, ensuring reliable vascular access in controlled clinical environments.

• How is the Pediatric Arterial Cannula supplied, and what does this mean for clinical use?

  The Pediatric Arterial Cannula is supplied as a single-use, sterile, and non-pyrogenic disposable device. This means each cannula is intended for one-time use only, reducing the risk of contamination or cross-infection between patients. Clinicians must adhere to sterile handling protocols during setup and use, as reuse is not recommended to maintain safety and efficacy.

• Is the device biocompatible, and what standards does it meet?

  Yes, the Pediatric Arterial Cannula meets stringent biocompatibility standards to ensure patient safety. It adheres to USP <23> and USP <24> for biological reactivity testing and ISO 10993 for biological evaluation, confirming its compatibility with pediatric tissues and minimal risk of adverse reactions during use.

• What sizes or models are available for the Pediatric Arterial Cannula?

  While the provided data does not specify exact size ranges or model variations, the device is explicitly designed for pediatric use, implying it is available in smaller diameters suitable for young patients. For precise sizing, clinicians should refer to the manufacturer’s packaging or technical documentation, which typically lists compatible artery diameters and recommended models for different patient weights or ages.

• How should the Pediatric Arterial Cannula be stored to maintain sterility and functionality?

  The cannula should be stored in its original, sealed packaging until use to preserve sterility. It must be kept in a clean, dry environment protected from direct sunlight, extreme temperatures, or physical damage. Once opened, it should be used immediately, as prolonged exposure to air or handling could compromise sterility and integrity. Follow the manufacturer’s storage instructions for optimal performance.