← Product Code [FJH](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJH) · K822395

# CF 1211 CAPILLARY FLOW DIALYZER CODE (K822395)

_Travenol Laboratories, S.A. · FJH · Aug 12, 1982 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJH/K822395

## Device Facts

- **Applicant:** Travenol Laboratories, S.A.
- **Product Code:** [FJH](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJH.md)
- **Decision Date:** Aug 12, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5830
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that includes disposable inserts consisting of layers of semipermeable membranes which are sandwiched between support plates. The device is used with the extracorporeal blood system and the dialysate delivery system of the hemodialysis system and accessories (§ 876.5820).

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJH/K822395](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJH/K822395)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com