Class 2 Device Recall Cronus | 合法醫療器材資訊網
2004年7月20日—Product,CronusEndovascularGuidewire,Length210cm(partialcoat),Diameter0.014inch,PartNumber001-001096-3.CodeInformation ...
References
Related Medical Device
Recalls (www.accessdata.fda.gov)
K021363
(www.accessdata.fda.gov)
medical device recalls
(www.fda.gov)
Code of Federal Regulations
(CFR) Title 21 §7.55
(www.accessdata.fda.gov)
510(K)s with Product Code = NFN
and Original Applicant = STEREOTAXIS, INC.
(www.accessdata.fda.gov)
Date Initiated by Firm
January 27, 2004
Date Posted
July 20, 2004
Recall Status1
Terminated 3 on October 31,
2005
Recall Number
Z-0591-04
Recall Event ID
28254[1]
510(K)Number
...
“Cronus”Guidewire “Cronus”Guidewire 晶聖實業有限公司 AI 可 攜 式 心電圖 記錄 器 Rossmax 血糖機 “DA. AI” Truncal orthosis(Non-Sterile) 辰豫科技有限公司 “樂可仕”手術用光源系統 hla-b27 test kit "HUTTINGER" ULTRASONIC THERAPY UNIT
“可樂那斯”導絲“Cronus”Guidewire} | 合法醫療器材資訊網
可樂那斯”導絲“Cronus”Guidewire / 此導絲係在經皮穿腔冠狀動脈擴張術或其他血管內介入性治療操作時，用來引導經過導絲送入冠狀動脈或週邊血管的導管或其他 ... Read More
Cronus Guidewire, Model 001 | 合法醫療器材資訊網
FDA premarket device registration for Cronus Guidewire, Model 001-001470-1 distributed by STEREOTAXIS, INC. Read More
Appendix 1 | 合法醫療器材資訊網
2005年2月8日 — The Cronus Guide Wires are conventional 0.014-hydrophilically coated characteristics endovascular guide wire modified to accommodate ... Read More
Class 2 Device Recall Cronus | 合法醫療器材資訊網
2004年7月20日 — Product, Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3. Code Information ... Read More
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