Synchro2 Support Guidewire— 510(k) K190843

Substantially Equivalent

Stryker

FDA 510(k) clearance K190843 for Synchro2 Support Guidewire, Substantially Equivalent on 2019-05-01. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2019-04-01
Decision date: 2019-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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.