Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette— 510(k) K171427

Substantially Equivalent

Medtronic Vascular, Inc.

FDA 510(k) clearance K171427 for Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette, Substantially Equivalent on 2017-06-13. Applicant: Medtronic Vascular, Inc..

Clearance details

Applicant: Medtronic Vascular, Inc.
Product code: Code OTD
Advisory panel: Cardiovascular
Date received: 2017-05-15
Decision date: 2017-06-13
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, 2020-01-01 through 2026-04-23. 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.