VOYAGER PERITONEAL DIALYSIS SYSTEM— 510(k) K103220

Substantially Equivalent

Deka Research & Development Corp.

FDA 510(k) clearance K103220 for VOYAGER PERITONEAL DIALYSIS SYSTEM, Substantially Equivalent on 2011-07-29. Applicant: Deka Research & Development Corp..

Clearance details

Applicant: Deka Research & Development Corp.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 2010-11-01
Decision date: 2011-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

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Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.