PICC Tip Positioning Aid— 510(k) K152261

Substantially Equivalent

Nostix, LLC

FDA 510(k) clearance K152261 for PICC Tip Positioning Aid, Substantially Equivalent on 2015-10-21. Applicant: Nostix, LLC.

Clearance details

Applicant: Nostix, LLC
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2015-08-11
Decision date: 2015-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.