DeviceClearance

K033726

Substantially Equivalent

PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER

Applicant
Precision Vascular
Product code
KRA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
West Valley City, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KRA

product code KRA
Death
234
Injury
1,029
Malfunction
3,012
Other
2
Total
4,277

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.