APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH— 510(k) K140036

Substantially Equivalent

Aptus Endosystems, Inc.

FDA 510(k) clearance K140036 for APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH, Substantially Equivalent on 2014-02-06. Applicant: Aptus Endosystems, Inc..

Clearance details

Applicant: Aptus Endosystems, Inc.
Product code: Code OTD
Advisory panel: Cardiovascular
Date received: 2014-01-07
Decision date: 2014-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, 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.