STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER— 510(k) K113023

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K113023 for STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER, Substantially Equivalent on 2012-12-21. Applicant: Nxstage Medical, Inc..

Clearance details

Applicant: Nxstage Medical, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2011-10-11
Decision date: 2012-12-21
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.