K101777

Substantially Equivalent

PIONEER PLUS CATHETER, MODEL PLUS 120

Applicant
Medtronic Vascular
Product code
PDU
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Santa Rosa, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code PDU

product code PDU
Malfunction
793
Total
793

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.