DeviceClearance

FRESENIUS HEMOFLOW F3, F4, F5, F7— 510(k) K874872

Substantially Equivalent

Seratronics, Inc.

FDA 510(k) clearance K874872 for FRESENIUS HEMOFLOW F3, F4, F5, F7, Substantially Equivalent on 1988-02-19. Applicant: Seratronics, Inc.. Device class: 2.

Clearance details

Applicant
Seratronics, Inc.
Product code
Code FJI
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Concord, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FJI

product code FJI
Death
2
Total
2

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

Recalls naming K874872

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K874872.

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