FJH · Dialyzer, Disposable
Gastroenterology, Urology · 21 CFR 876.5830 · Class 2
Overview
| Product Code | FJH |
|---|---|
| Device Name | Dialyzer, Disposable |
| Regulation | 21 CFR 876.5830 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Life-Sustaining | Yes |
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).
Classification Rationale
Class II (performance standards).
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920697 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | National Medical Care, Medical Products Div., Inc. | Sep 21, 1992 | SESE |
| K861646 | BIO-CARB D16000, D16001, AND D17000 | Societe D' Analyses Bio-Pharmaceutiques,Inc. | Aug 7, 1986 | SESE |
| K852764 | IDECAP DIALYZER | Trans-National Trade Development Corp. | Sep 20, 1985 | SESE |
| K822395 | CF 1211 CAPILLARY FLOW DIALYZER CODE | Travenol Laboratories, S.A. | Aug 12, 1982 | SESE |
Top Applicants
- Travenol Laboratories, S.A. — 1 clearance
- Trans-National Trade Development Corp. — 1 clearance
- Societe D' Analyses Bio-Pharmaceutiques,Inc. — 1 clearance
- National Medical Care, Medical Products Div., Inc. — 1 clearance
