DeviceClearance

K952887

Substantially Equivalent

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

Applicant
Meadox Medicals, Div. Boston Scientific Corp.
Product code
LJE
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oakland, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LJE

product code LJE
Death
6
Total
6

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 →

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