ADD-VANTAGE ADDAPTOR— 510(k) K133602

Name: FDA 510(k) clearance K133602
Creator: U.S. Food and Drug Administration
Published: 2014-01-24

Substantially Equivalent

Hospira, Inc.

FDA 510(k) clearance K133602 for ADD-VANTAGE ADDAPTOR, Substantially Equivalent on 2014-01-24. Applicant: Hospira, Inc.. Device class: 2.

Clearance details

Applicant: Hospira, Inc.
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2013-11-25
Decision date: 2014-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

Download summary PDF View on FDA.gov ↗

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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.