MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION— 510(k) K053286

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K053286 for MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION, Substantially Equivalent on 2005-12-22. Applicant: Nxstage Medical, Inc..

Clearance details

Applicant: Nxstage Medical, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2005-11-25
Decision date: 2005-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Lawrence, MA, US

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.