MULTI-DRIP INFUSION CATHETER— 510(k) K042246
Substantially EquivalentAdvanced Infusion, Inc.
FDA 510(k) clearance K042246 for MULTI-DRIP INFUSION CATHETER, Substantially Equivalent on 2004-08-31. Applicant: Advanced Infusion, Inc..
Clearance details
- Applicant
- Advanced Infusion, Inc.
- Product code
- Code MEB
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
Adverse events under product code MEB
product code MEB- Death
- 6
- Injury
- 160
- Malfunction
- 10,053
- Other
- 5
- Total
- 10,224
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.