DeviceClearance

K171427

Substantially Equivalent

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette

Applicant
Medtronic Vascular, Inc.
Product code
OTD
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 OTD

product code OTD
Death
31
Injury
172
Total
203

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.