EPIFUSE CATHETER CONNECTOR, MODEL: 4909E— 510(k) K092657
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K092657 for EPIFUSE CATHETER CONNECTOR, MODEL: 4909E, Substantially Equivalent on 2009-11-04. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Keene, NH, US
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Adverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
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.