VASCON ROAMER MICROCATHETER— 510(k) K053310

Name: FDA 510(k) clearance K053310
Creator: U.S. Food and Drug Administration
Published: 2008-07-03

Substantially Equivalent

Vascon, LLC

FDA 510(k) clearance K053310 for VASCON ROAMER MICROCATHETER, Substantially Equivalent on 2008-07-03. Applicant: Vascon, LLC. Device class: 2.

Clearance details

Applicant: Vascon, LLC
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2005-11-28
Decision date: 2008-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vascon, LLC

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K052004 — VASCON NEUROPATH GUIDING CATHETER2006-01-19
K043387 — VASCON POLARIS GUIDING CATHETER2005-02-16
K033633 — VASCON POLARIS GUIDING CATHETER2004-02-18

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.