FDA 510(k)

輸尿管導尿管，清潔輸尿管導尿管，柔軟尖端防水處理輸尿管導尿管

K 號：K171043 · 2017-12-21

決定日期2017-12-21

產品代碼EYB

諮詢委員會GU

決定相當於

器材摘要

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K171043. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters?

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Coloplast Corp.. The 510(k) number is K171043.

When did Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters receive FDA 510(k) clearance?

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters received FDA 510(k) clearance on 2017-12-21, under 510(k) number K171043.

Who is the listed applicant for Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters?

The FDA product code for Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters is EYB.

其他以 Coloplast Corp. 為申請人之記錄

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相關器械（代碼：EYB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K192183RocaTub 腎管導尿管Promepal Sam K191187多尼爾 MINNOW 腎管導管Dornier Medtech America, Inc.K183323UPJ 遏流氣球導管Cook Incorporated K182695尾管輸尿管導管套件，Sof-Flex AQ 遮蔽尾管輸尿管導管Cook Incorporated K182122腎盂輸尿管導管Coloplast Corp.K180182雙腔輸尿管進入導管，Flexi-Tip雙腔輸尿管進入導管Cook Incorporated

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