5 FR Dual Lumen Piper PICC— 510(k) K181904

Substantially Equivalent

Piper Access, LLC

FDA 510(k) clearance K181904 for 5 FR Dual Lumen Piper PICC, Substantially Equivalent on 2018-09-25. Applicant: Piper Access, LLC.

Clearance details

Applicant: Piper Access, LLC
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2018-07-16
Decision date: 2018-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.