Intersept Pediactric Extracorporeal Filt

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

510(k) Number

K823108 ↗

FDA Product Code

DTM

Device Class

Class II

Regulation

21 CFR Part 870.4260

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Extracorporeal Medical Specialities, Inc. →

• What is the primary clinical purpose of the Intersect Pediatric Extracorporeal Filt during cardiopulmonary bypass procedures?

  The Intersect Pediatric Extracorporeal Filt is designed specifically for pediatric patients undergoing extracorporeal circulation to filter particulate matter and debris from the bloodstream during cardiopulmonary bypass procedures. By removing these contaminants, it helps ensure safe and effective perfusion by maintaining blood quality during critical cardiac interventions.

• Is this device intended for reuse, or is it meant to be used only once per patient?

  This device is supplied as a single-use, sterile disposable filter, meaning it is intended for one-time use per patient. Reuse is not recommended, as it could compromise sterility and functionality, potentially compromising patient safety during cardiopulmonary bypass.

• How should the Intersect Pediatric Extracorporeal Filt be stored to maintain its integrity?

  The filter must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is a sterile disposable, it should be kept in its original packaging until immediately before use, protected from contamination, moisture, and physical damage. Avoid exposure to extreme temperatures or direct sunlight.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Intersect Pediatric Extracorporeal Filt received FDA 510(k) clearance (K823108) under the Traditional pathway, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it meets the same performance standards as an existing approved filter for arterial line use in cardiopulmonary bypass, ensuring its safety and effectiveness for pediatric patients in controlled clinical settings like operating rooms.

• Can this filter be used in environments where MRI scans are performed, or is it MRI-compatible?

  The Intersect Pediatric Extracorporeal Filt is not MRI-compatible. It should not be used in proximity to MRI machines, as the magnetic fields could potentially affect its structure or performance, posing risks to both the device and the patient.