DeviceClearance

Product code LJS— General Hospital

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

Classification name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class
Class 2
Regulation
21 CFR 880.5970
Advisory panel
General Hospital
Total cleared
302
First cleared
Most recent

Market context for product code LJS

FDA has cleared 302 devices under product code LJS between 1983 and 2026, filed by 108 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LJS

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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LJS

1–100 of 302

Data sourced from openFDA. This site is unofficial and independent of the FDA.