K040447

Substantially Equivalent

TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

Applicant
Boston Scientific Corp
Product code
LQC
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Natick,, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LQC

product code LQC
Death
7
Injury
247
Malfunction
956
Total
1,210

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.