Trio-CT® Triple Lumen Catheter w/ Curved Extensions— 510(k) K232945
UnknownMedical Components, Inc. (dba MedComp)
FDA 510(k) clearance K232945 for Trio-CT® Triple Lumen Catheter w/ Curved Extensions, Unknown on 2023-11-16. Applicant: Medical Components, Inc. (dba MedComp). Device class: 2.
Clearance details
- Applicant
- Medical Components, Inc. (dba MedComp)
- Product code
- Code NIE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Harleysville, PA, US
Recent devices under product code NIE
view allMore clearances from Medical Components, Inc. (dba MedComp)
view all- K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
- K192807 — Duo-Flow Side x Side Double Lumen Catheter
- K173667 — 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
- K180567 — C3 Wave System
- K170934 — C3 Wave System
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.