Therapeutic Exchange System

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

510(k) Number

K831423 ↗

FDA Product Code

LQQ

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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See all devices from Extracorporeal Medical Specialities, Inc. →

• What is the Therapeutic Exchange System used for in clinical settings?

  The Therapeutic Exchange System is designed for extracorporeal blood purification, specifically to selectively remove pathogenic antibodies or immune complexes from plasma during therapeutic exchange procedures. It is commonly used in treatments requiring plasma exchange or immunoadsorption therapy, where the goal is to filter and treat blood outside the body.

• Is the Therapeutic Exchange System intended for single-use or repeated use?

  The Therapeutic Exchange System is explicitly supplied as a single-use, sterile device. This design ensures patient safety and device efficacy, as reuse could compromise sterility and performance. Always follow sterile medical device protocols during handling and storage.

• How should the Therapeutic Exchange System be stored to maintain its integrity?

  Since it is a sterile, single-use device, storage must adhere to strict sterile medical device protocols. The system should be kept in its original packaging until immediately before use, protected from contamination, moisture, and extreme temperatures. Always check the packaging for integrity before use.

• What regulatory pathway was followed for FDA clearance of this device?

  The Therapeutic Exchange System underwent a traditional 510(k) clearance process (K831423) and is classified as a Class III medical device under FDA regulations. The clearance was granted in 1984, with a decision code indicating it was determined to be substantially equivalent to a predicate device.