DeviceClearance

Product code BSY— Anesthesiology

SUCTION CATHETER KIT

Classification name
Catheters, Suction, Tracheobronchial
Device class
Class 1
Regulation
21 CFR 868.6810
Advisory panel
Anesthesiology
Total cleared
116
First cleared
Most recent

Market context for product code BSY

FDA has cleared 116 devices under product code BSY between 1976 and 2003, filed by 79 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

last 15 years

Top applicants under product code BSY

Adverse events under product code BSY

product code BSY
Death
3
Injury
155
Malfunction
959
Total
1,117

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 BSY

1–100 of 116

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