FDA 510(k)

Well Lead Ureteral Access Sheath

K番号: K151084 · 2016-01-07

決定日2016-01-07

製品コードFED

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

決定大幅同等

医療機器の概要

Well Lead Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K151084. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Well Lead Ureteral Access Sheath?

Well Lead Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K151084.

When did Well Lead Ureteral Access Sheath receive FDA 510(k) clearance?

Well Lead Ureteral Access Sheath received FDA 510(k) clearance on 2016-01-07, under 510(k) number K151084.

Who is the listed applicant for Well Lead Ureteral Access Sheath?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well Lead Ureteral Access Sheath?

The FDA product code for Well Lead Ureteral Access Sheath is FED.

申請者としてWell Lead Medical Co., Ltd.を記載するその他の記録

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact K220722PVC水親性尿道カテーテル K220036Wellead Ureteral Catheter K211543Wei Nasal Jet Tube K211814Wellead Endoscopic Seal K202134Well Lead All Silicone Foley Catheter with Temperature Sensor

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公式ソース

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