St Family Of Hollow Fiber Dialyzers

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

510(k) Number

K844756 ↗

FDA Product Code

FKQ

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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

• What is the St Family Of Hollow Fiber Dialyzers used for?

  The St Family Of Hollow Fiber Dialyzers is used in dialysis, specifically for dialysate delivery to multiple patients, and is applied in the medical specialties of Gastroenterology and Urology.

• How is the St Family Of Hollow Fiber Dialyzers supplied?

  The device is supplied with a product code of FKQ and a regulation number of 876.5820, and has been cleared by the FDA as substantially equivalent.

• Is the St Family Of Hollow Fiber Dialyzers a single-use or reusable device?

  The description does not explicitly state whether the device is single-use or reusable, but it is classified as a class 2 device and has a specific product code and regulation number.

• What are the relevant regulatory details for the St Family Of Hollow Fiber Dialyzers?

  The device has been cleared by the FDA with a Traditional clearance type, and is classified as substantially equivalent with a decision code of SESE.