ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384— 510(k) K022203
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K022203 for ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384, Substantially Equivalent on 2002-08-01. Applicant: Abbott Laboratories.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code MEA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Abbott Park, IL, US
Adverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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.