MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519— 510(k) K093406

Substantially Equivalent

AngioDynamics, Inc.

FDA 510(k) clearance K093406 for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519, Substantially Equivalent on 2010-03-25. Applicant: AngioDynamics, Inc..

Clearance details

Applicant: AngioDynamics, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2009-11-02
Decision date: 2010-03-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Queensburgy, NY, 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.