FDA 510(k) Premarket Notification K171618: Symetrex Long Term Hemodialysis Catheter

Submission Details & Decision

Normalized public record details for 510(k) notification K171618.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K171618

Applicant / Sponsor

Medcomp (Dba Medical Components, Inc.)

Device Name

Symetrex Long Term Hemodialysis Catheter

Product Code

MSD

Decision Date

2017-11-16

Decision / Status

Unknown (SESK)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

2017-06-02

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.