PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO— 510(k) K980381

Substantially Equivalent

Carmel Pharma Ab.

FDA 510(k) clearance K980381 for PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO, Substantially Equivalent on 1998-03-03. Applicant: Carmel Pharma Ab..

Clearance details

Applicant: Carmel Pharma Ab.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1998-02-02
Decision date: 1998-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gothenburg, 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.