\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR— 510(k) K022536

Substantially Equivalent

Fresenius Medical Care

FDA 510(k) clearance K022536 for \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR, Substantially Equivalent on 2002-10-30. Applicant: Fresenius Medical Care.

Clearance details

Applicant: Fresenius Medical Care
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 2002-08-01
Decision date: 2002-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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.