Heat Exchanger Coil

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790756 ↗

FDA Product Code

DTR

Device Class

Class II

Regulation

21 CFR Part 870.4240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Heat Exchanger Coil used for?

  The Heat Exchanger Coil is a device designed for medical applications in cardiopulmonary bypass procedures. It functions as a heat exchanger specifically manufactured for cardiovascular applications by Delta Medical Industries.

• Is the Heat Exchanger Coil single-use or reusable?

  The Heat Exchanger Coil is supplied as either a single-use or reusable product depending on the specific model selected. The manufacturer offers various models with different usage specifications to meet clinical needs.

• What regulatory status does the Heat Exchanger Coil have?

  The Heat Exchanger Coil is regulated under FDA 510(k) clearance with product code DTR. It received traditional clearance with decision code SESE on June 11, 1979, and is classified as a Class II device for cardiovascular applications.

• What models and sizes are available for the Heat Exchanger Coil?

  The Heat Exchanger Coil is available in various models and sizes as specified by Delta Medical Industries. The specific models and dimensions would be detailed in the manufacturer's product documentation and specifications.