DeviceClearance

Product code GBA— General, Plastic Surgery

BALLOON RETENTION CHEST CATHETER

Classification name
Catheter, Balloon Type
Device class
Class 1
Regulation
21 CFR 878.4200
Advisory panel
General, Plastic Surgery
Total cleared
5
First cleared
Most recent

Market context for product code GBA

FDA has cleared 5 devices under product code GBA between 1978 and 1986, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code GBA

Adverse events under product code GBA

product code GBA
Death
2
Total
2

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 GBA

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