QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT— 510(k) K141869

Substantially Equivalent

Hemedex Incorporated

FDA 510(k) clearance K141869 for QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT, Substantially Equivalent on 2014-10-10. Applicant: Hemedex Incorporated.

Clearance details

Applicant: Hemedex Incorporated
Product code: Code GWM
Advisory panel: Neurology
Date received: 2014-07-11
Decision date: 2014-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.