FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Trio-CT® Triple Lumen Catheter w/ Curved Extensions
K Number: K232945
·
Decision Nov 16, 2023
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
11
Applicant Total
1
Review Days
57
Basic Information
- Device Name
- Trio-CT® Triple Lumen Catheter w/ Curved Extensions
- K Number
- K232945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medical Components Inc. (Dba MedComp)
- Date Received
- September 20, 2023
- Decision Date
- November 16, 2023
- Product Code
- NIE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | FDA class 2 | Gastroenterology, Urology |
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