PHASEAL PROTECTOR P14, P21, P28 AND P50— 510(k) K090634
Substantially EquivalentCarmel Pharma Ab.
FDA 510(k) clearance K090634 for PHASEAL PROTECTOR P14, P21, P28 AND P50, Substantially Equivalent on 2009-03-23. Applicant: Carmel Pharma Ab.. Device class: 2.
Clearance details
- Applicant
- Carmel Pharma Ab.
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gothenburg, SE
Recent devices under product code LHI
view allMore clearances from Carmel Pharma Ab.
view all- K110023 — INFUSION ADAPTER C100
- K092782 — INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
- K060866 — PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
- K023747 — PHASEAL
- K001368 — PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
Adverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
Source: openFDA MAUDE database, through . 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.