免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

MICRUSFRAME 10 拉伸抗力微线圈輸送系統，MICRUSFRAME 18 拉伸抗力微线圈輸送系統，DELTAFILL 18 拉伸抗力微线圈輸送系統，DELTAXSFT 10 拉伸抗力微线圈輸送系統，GALAXY G3 FILL 及 GALAXY G3 XSFT 拉伸抗力微线圈輸送系統

K 號：K171747 · 2017-07-14

申請人Codman & Shurtleff, Inc.
決定日期2017-07-14
產品代碼HCG
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K171747. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System?

MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K171747.

When did MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System receive FDA 510(k) clearance?

MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K171747.

Who is the listed applicant for MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System?

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

What is the FDA product code for MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System?

The FDA product code for MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System is HCG.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Codman & Shurtleff, 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。

K193380CERENOVUS 大孔內管；CERENOVUS 吸引管路組K191237CERENOVUS 大孔內腸導管K173192CereLink ICP感測器基本套件、CereLink ICP感測器金屬頭蓋螺釘套件、CereLink ICP感測器塑膠頭蓋螺釘套件、CereLink ICP感測器心室針套件K172537科德曼EDS 3 CSF外引流系統，科德曼EDS 3 CSF外引流系統收集袋K172022CODMAN 腦室內腫瘤閥、導管及配件（組裝）K171862GALAXY G3 Mini 微线圈輸送系統

查看所有 11 項裝置 →

相關器械（代碼：HCG）

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。

K262419MICRUSFRAME (MFR100202)；MICRUSFRAME (MFR100253)；MICRUSFRAME (MFR100305)；MICRUSFRAME (MFR100356)；MICRUSFRAME (MFR100407)；MICRUSFRAME (MFR100412)；MICRUSFRAME (MFR100509)；MICRUSFRAME (MFR100517)；MICRUSFRAME (MFR100611)；MICRUSFRAME (MFR100626)；MICRUSFRAME (MFR100713)；MICRUSFRAME (MFR100730)；MICRUSFRAME (MFR100816)；MICRUSFRAME (MFR100829)；MICRUSFRAME (MFR140225)；MICRUSFRAME (MFR140303)；MICRUSFRAME (MFR140304)；MICRUSFRAME (MFR140306)；MICRUSFRAME (MFR140406)；MICRUSFRAME (MFCerenovus, Inc.K261772目標Xtra可拆式線圈Stryker NeurovscularK260351Numen™ 赫利亞栓塞系統；NumenFR™ 分離系統MicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima 結構系統（OptiOne 結構系統）Balt USA, LLCK252694目標可拆式線圈Stryker NeurovascularK251832InZone IST 分離系統；IZDS 連接線Stryker Neurovascular

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑