BIO-CARB D16000, D16001, AND D17000
Device Facts
| Record ID | K861646 |
|---|---|
| Device Name | BIO-CARB D16000, D16001, AND D17000 |
| Applicant | Societe D' Analyses Bio-Pharmaceutiques,Inc. |
| Product Code | FJH · Gastroenterology, Urology |
| Decision Date | Aug 7, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5830 |
| Device Class | Class 2 |
Regulatory Classification
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).
