SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS— 510(k) K864784

Name: FDA 510(k) clearance K864784
Creator: U.S. Food and Drug Administration
Published: 1987-01-20

Substantially Equivalent

Cd Medical, Inc.

FDA 510(k) clearance K864784 for SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS, Substantially Equivalent on 1987-01-20. Applicant: Cd Medical, Inc.. Device class: 2.

Clearance details

Applicant: Cd Medical, Inc.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1986-12-08
Decision date: 1987-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

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K894106 — DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST1989-11-08
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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.