NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE— 510(k) K093069

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K093069 for NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE, Substantially Equivalent on 2010-10-23. Applicant: Nxstage Medical, Inc..

Clearance details

Applicant: Nxstage Medical, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2009-09-30
Decision date: 2010-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrence, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.