CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15— 510(k) K871471

Clearance details

Applicant

Travenol Laboratories, S.A.

Product code

Code FJI

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

1987-04-14

Decision date

1987-06-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Round Lake, IL, US

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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 →