CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP— 510(k) K013714
Substantially EquivalentCodan US Corp.
FDA 510(k) clearance K013714 for CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP, Substantially Equivalent on 2002-03-28. Applicant: Codan US Corp.. Device class: 2.
Clearance details
- Applicant
- Codan US Corp.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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More clearances from Codan US Corp.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.