FDA 510(k)

BASHIR™ .035內血管導管，BASHIR™ S-B .035內血管導管

K 號：K231653 · 2023-07-03

決定日期2023-07-03

產品代碼QEY

諮詢委員會履歷

決定相當於

器材摘要

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Thrombolex, Inc.. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K231653. 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™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Thrombolex, Inc.. The 510(k) number is K231653.

When did BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter receive FDA 510(k) clearance?

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter received FDA 510(k) clearance on 2023-07-03, under 510(k) number K231653.

Who is the listed applicant for BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

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™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

The FDA product code for BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter 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。

K222095BASHIR內血管導管參考編號7201，BASHIR S-B內血管導管，參考編號7101 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.K222095BASHIR內血管導管參考編號7201，BASHIR S-B內血管導管，參考編號7101Thrombolex, 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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