DIALYZER, HF 130 HOLLOW FIBER— 510(k) K760252

Name: FDA 510(k) clearance K760252
Creator: U.S. Food and Drug Administration
Published: 1976-10-15

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K760252 for DIALYZER, HF 130 HOLLOW FIBER, Substantially Equivalent on 1976-10-15. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1976-07-19
Decision date: 1976-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FJI

view all

K190459 — Hemoflow F3 and F4 Dialyzers2019-08-23
K122952 — NIPRO PUREFLUX-L HEMODIALYZER2013-12-04
K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR2005-05-27
K010366 — DISPOSABLE STORAGE CAP2001-11-28
K011148 — ULTRACONCENTRATOR SYSTEM2001-06-13

More clearances from Cobe Laboratories, Inc.

view all

K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR1993-05-11
K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC1991-03-22
K905793 — COBE CENTRY 2 BICART OPTION KIT1991-02-12
K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT1991-02-11
K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR1990-12-27

Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.