INFUSION ADAPTER C100— 510(k) K110023

Substantially Equivalent

Carmel Pharma Ab.

FDA 510(k) clearance K110023 for INFUSION ADAPTER C100, Substantially Equivalent on 2011-04-12. Applicant: Carmel Pharma Ab..

Clearance details

Applicant: Carmel Pharma Ab.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2011-01-03
Decision date: 2011-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molndal, SE

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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.