Symetrex Long Term Hemodialysis Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K171618 ↗

FDA Product Code

MSD

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

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See all devices from Medcomp (Medical Components, Inc.) →

• What is the Symetrex Long Term Hemodialysis Catheter used for?

  The Symetrex Long Term Hemodialysis Catheter is designed for chronic hemodialysis and apheresis procedures. It features a symmetric tip dual lumen design and can be inserted percutaneously or by cut down, with catheters longer than 37 cm specifically indicated for femoral placement.

• How is the Symetrex Hemodialysis Catheter supplied?

  The device is supplied as a single-use catheter. It is manufactured by Medcomp (Dba Medical Components, Inc.) and is classified as a Class II device for hemodialysis applications under FDA 510K clearance with product code MSD.

• What insertion methods are available for the Symetrex Catheter?

  The Symetrex Long Term Hemodialysis Catheter may be inserted either percutaneously or by cut down. Catheters with an implant length greater than 37 cm are specifically indicated for femoral placement, providing flexibility in clinical applications.

• What is the regulatory status of the Symetrex Hemodialysis Catheter?

  The device is regulated under FDA 510K clearance with product code MSD. It is classified as a Class II device for hemodialysis applications, manufactured by Medcomp (Dba Medical Components, Inc.) and received clearance on November 16, 2017.