DeviceClearance

Product code FOS— General Hospital

ARGYLE NEO-SERT

Classification name
Catheter, Umbilical Artery
Device class
Class 2
Regulation
21 CFR 880.5200
Advisory panel
General Hospital
Total cleared
34
First cleared
Most recent

Market context for product code FOS

FDA has cleared 34 devices under product code FOS between 1977 and 2021, filed by 19 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 FOS

Adverse events under product code FOS

product code FOS
Death
12
Other
1
Total
13

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 FOS

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