Last synced on 9 December 2022 at 11:04 pm

Dialyzer, Disposable

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5830
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 876.5830 Hemodialyzer with disposable insert (Kiil type)

§ 876.5830 Hemodialyzer with disposable insert (Kiil type).

(a) 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).

(b) Classification. Class II (performance standards).

[48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]

Dialyzer, Disposable

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5830
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 876.5830 Hemodialyzer with disposable insert (Kiil type)

§ 876.5830 Hemodialyzer with disposable insert (Kiil type).

(a) 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).

(b) Classification. Class II (performance standards).

[48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]