PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER— 510(k) K001368

Substantially Equivalent

Carmel Pharma Ab.

FDA 510(k) clearance K001368 for PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER, Substantially Equivalent on 2000-05-12. Applicant: Carmel Pharma Ab..

Clearance details

Applicant: Carmel Pharma Ab.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2000-05-01
Decision date: 2000-05-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Gothenburg, SE

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.