HOLLOW FIBER DIALYZERS— 510(k) K820743

Name: FDA 510(k) clearance K820743
Creator: U.S. Food and Drug Administration
Published: 1982-06-23

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K820743 for HOLLOW FIBER DIALYZERS, Substantially Equivalent on 1982-06-23. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1982-03-19
Decision date: 1982-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, 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 Terumo Medical Corp.

view all

K111606 — PINNACLE PRECISION ACCESS SYSTEM2011-10-03
K111556 — GLIDECROSS SUPPORT CATHETER2011-07-29
K110540 — TERUMO SUPPORT CATHETER2011-05-13
K102008 — GLIDESHEATH2010-07-21
K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2009-05-29

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.