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— 510(k) K173667

Clearance details

Applicant

Medical Components, Inc. (dba MedComp)

Product code

Code MSD

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

2017-11-30

Decision date

2018-05-17

Decision

Unknown

Clearance type

Traditional

Location

Harleysville, PA, US

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• K211410 — GlidePath 13F Long-Term Hemodialysis Catheter2021-06-04
• K203767 — Pristine Long-Term Hemodialysis Catheter2021-04-02

• K232945 — Trio-CT­® Triple Lumen Catheter w/ Curved Extensions2023-11-16
• K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes2020-09-03
• K192807 — Duo-Flow Side x Side Double Lumen Catheter2020-04-23
• K183219 — Trio-CT Triple Lumen Catheter2019-06-14
• K181175 — 12F Tri-Flow Triple Lumen Catheter2018-07-05

Death

67

Injury

545

Malfunction

3,661

Total

4,273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →