FDA 510(k)

BASHIR內血管導管參考編號7201，BASHIR S-B內血管導管，參考編號7101

K 號：K222095 · 2023-04-20

決定日期2023-04-20

產品代碼QEY

諮詢委員會履歷

決定相當於

器材摘要

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is the device name listed in this FDA 510(k) record. The listed applicant is Thrombolex, Inc.. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K222095. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Thrombolex, Inc.. The 510(k) number is K222095.

When did BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 receive FDA 510(k) clearance?

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 received FDA 510(k) clearance on 2023-04-20, under 510(k) number K222095.

Who is the listed applicant for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

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

What is the FDA product code for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

The FDA product code for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is QEY.

其他以 Thrombolex, Inc. 為申請人之記錄

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。

K231653BASHIR™ .035內血管導管，BASHIR™ S-B .035內血管導管 K211061BASHIR 經腔內神經導管（參考編號 7201），BASHIR Plus 10 經腔內神經導管（參考編號 7210），BASHIR Plus 20 經腔內神經導管（參考編號 7220），BASHIR Plus 30 經腔內神經導管（參考編號 7230），BASHIR Plus 40 經腔內神經導管（參考編號 7240）K193071巴希爾加內血管導管 K192598巴希爾S-B內血管導管，參考編號7101 K183290巴希爾內血管導管型號7201，巴希爾N-X內血管導管，模式7200

相關器械（代碼：QEY）

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。

K260149對比™ 管針 (VS110-9NB)Liquet Medical, Inc.K251318變頻調節輸液針管Argon Medical Devices, Inc.K241851對比™ 管針 (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035內血管導管，BASHIR™ S-B .035內血管導管Thrombolex, Inc.K220866EKOS+內血管設備Boston Scientific K213422EkoSonic內血管設備，EKOS+內血管設備Boston Scientific Corporation

官方來源

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