Trio-CT Triple Lumen Catheter— 510(k) K183219
UnknownMedical Components, Inc. (dba MedComp)
FDA 510(k) clearance K183219 for Trio-CT Triple Lumen Catheter, Unknown on 2019-06-14. Applicant: Medical Components, Inc. (dba MedComp).
Clearance details
- Applicant
- Medical Components, Inc. (dba MedComp)
- Product code
- Code NIE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Harleysville, PA, US
Adverse events under product code NIE
product code NIE- Death
- 9
- Other
- 1
- Total
- 10
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.