APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH— 510(k) K121168

Substantially Equivalent

Aptus Endosystems, Inc.

FDA 510(k) clearance K121168 for APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH, Substantially Equivalent on 2012-08-08. Applicant: Aptus Endosystems, Inc..

Clearance details

Applicant: Aptus Endosystems, Inc.
Product code: Code OTD
Advisory panel: Cardiovascular
Date received: 2012-04-17
Decision date: 2012-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
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.