Dimesol Tubing Sets for Hemodialysis— 510(k) K171952

Substantially Equivalent

Dimesol, Inc.

FDA 510(k) clearance K171952 for Dimesol Tubing Sets for Hemodialysis, Substantially Equivalent on 2018-03-30. Applicant: Dimesol, Inc..

Clearance details

Applicant: Dimesol, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-29
Decision date: 2018-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisberry, PA, US

Download summary PDF View on FDA.gov ↗

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.