SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD— 510(k) K052790

Substantially Equivalent

Cardinal Health, Alaris Products

FDA 510(k) clearance K052790 for SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD, Substantially Equivalent on 2005-12-23. Applicant: Cardinal Health, Alaris Products.

Clearance details

Applicant: Cardinal Health, Alaris Products
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2005-10-03
Decision date: 2005-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.