← Product Code [FKT](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FKT) · K801440

# SORB 10 DIALYSATE INFUSATE C1 INFUSATE (K801440)

_Organon Teknika Corp. · FKT · Jul 21, 1980 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FKT/K801440

## Device Facts

- **Applicant:** Organon Teknika Corp.
- **Product Code:** [FKT](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FKT.md)
- **Decision Date:** Jul 21, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5600
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FKT/K801440](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FKT/K801440)

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