TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV— 510(k) K002816

Substantially Equivalent

Transonic Systems, Inc.

FDA 510(k) clearance K002816 for TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV, Substantially Equivalent on 2000-11-22. Applicant: Transonic Systems, Inc..

Clearance details

Applicant: Transonic Systems, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 2000-09-11
Decision date: 2000-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ithaca, NY, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.