Clirans TE15 Hollow Fiber Dialyzer

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

510(k) Number

K801193 ↗

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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  FDA 510(k) K771210 Active Cleared 11 Jul 1977

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  FDA 510(k) K790105 Active Cleared 24 May 1979

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  FDA 510(k) K771430 Active Cleared 20 Sep 1977

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See all devices from Terumo America, Inc. →

• What is the CLIRANS TE15 Hollow Fiber Dialyzer used for?

  The CLIRANS TE15 Hollow Fiber Dialyzer is a disposable device designed to filter waste products from the blood during peritoneal dialysis procedures. It is specifically manufactured by Terumo America, Inc. for this purpose.

• Is the CLIRANS TE15 Hollow Fiber Dialysterile and single-use?

  Yes, the CLIRANS TE15 Hollow Fiber Dialyzer is supplied as a single-use product. It is designed to be used once and then discarded to ensure patient safety and prevent cross-contamination.

• What is the regulatory status of the CLIRANS TE15 Hollow Fiber Dialyzer?

  The CLIRANS TE15 Hollow Fiber Dialyzer is regulated under FDA 510(k) clearance K801193. It is classified under product code KDJ for gastroenterology and urology specialties, indicating its intended use in these medical fields.

• How is the CLIRANS TE15 Hollow Fiber Dialyzer supplied?

  The CLIRANS TE15 Hollow Fiber Dialyzer is supplied as a disposable device ready for use in peritoneal dialysis procedures. It is manufactured by Terumo America, Inc. and comes in a single-use format to ensure sterility and safety.