DeviceClearance

Product code JOL— General Hospital

DEKNATEL THORACIC CATHETER

Classification name
Catheter And Tip, Suction
Device class
Class 2
Regulation
21 CFR 880.6740
Advisory panel
General Hospital
Total cleared
84
First cleared
Most recent

Market context for product code JOL

FDA has cleared 84 devices under product code JOL between 1976 and 2005, filed by 61 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 JOL

Adverse events under product code JOL

product code JOL
Death
7
Injury
177
Malfunction
1,306
Other
1
Total
1,491

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 JOL

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