DeviceClearance

K191275

Substantially Equivalent

All’InCath 035M PTA Balloon Dilatation Catheter

Applicant
Nexstep Medical
Product code
LIT
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dijon, FR
Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT
Death
27
Injury
1,256
Malfunction
12,127
Total
13,410

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.