Compact Exchange Device 5C4197

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K851208 ↗

FDA Product Code

KDJ

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Travenol Laboratories, S.A. →

• What is the primary function of the Compact Exchange Device 5C4197?

  This device is an administration set specifically designed for use in peritoneal dialysis. It serves as a component to facilitate the delivery and exchange of dialysis fluids throughout the treatment process.

• Is this device intended for multiple uses?

  No, the Compact Exchange Device 5C4197 is supplied as a single-use, disposable medical product. It should be discarded after the intended dialysis procedure to ensure patient safety and maintain hygiene standards.

• What is the regulatory status of this administration set?

  The device is regulated under FDA 510(k) clearance K851208. It is classified as a Class 2 medical device under regulation number 876.5630, which pertains to administration sets for peritoneal dialysis.