FDA 510(k)

シメトレックス長期持続透析カテーテル

K番号: K171618 · 2017-11-16

申請者Medcomp (Dba Medical Components, Inc.)

決定日2017-11-16

製品コードMSD

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Unknown

医療機器の概要

Symetrex Long Term Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Dba Medical Components, Inc.). It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K171618. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

よくある質問

What is the Symetrex Long Term Hemodialysis Catheter?

Symetrex Long Term Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Medcomp (Dba Medical Components, Inc.). The 510(k) number is K171618.

When did Symetrex Long Term Hemodialysis Catheter receive FDA 510(k) clearance?

Symetrex Long Term Hemodialysis Catheter received FDA 510(k) clearance on 2017-11-16, under 510(k) number K171618.

Who is the listed applicant for Symetrex Long Term Hemodialysis Catheter?

The FDA 510(k) record lists Medcomp (Dba Medical Components, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Symetrex Long Term Hemodialysis Catheter?

The FDA product code for Symetrex Long Term Hemodialysis Catheter is MSD.

申請者としてMedcomp (Dba Medical Components, Inc.)を記載するその他の記録

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