SMARTSITE VIALSHIELD— 510(k) K132863

Substantially Equivalent

Yukon Medical, LLC

FDA 510(k) clearance K132863 for SMARTSITE VIALSHIELD, Substantially Equivalent on 2013-10-04. Applicant: Yukon Medical, LLC.

Clearance details

Applicant: Yukon Medical, LLC
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2013-09-12
Decision date: 2013-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.