XPRESSWAY RX CATHETER (6F LD-VERISON)— 510(k) K121301

Name: FDA 510(k) clearance K121301
Creator: U.S. Food and Drug Administration
Published: 2012-07-30

Substantially Equivalent

Kaneka Pharma America, LLC

FDA 510(k) clearance K121301 for XPRESSWAY RX CATHETER (6F LD-VERISON), Substantially Equivalent on 2012-07-30. Applicant: Kaneka Pharma America, LLC. Device class: 2.

Clearance details

Applicant: Kaneka Pharma America, LLC
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2012-05-01
Decision date: 2012-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.