510(k) Premarket Notification | 合法醫療器材資訊網
![510(k) Premarket Notification](https://i.imgur.com/6y29Lx7.jpg)
ProductCode:KRAApplicant:CORDISNEUROVASCULAR,INCDecisionDateTo:10/09/...prowlerselect(10,14,andplus)infusioncatheterswithandwithout ...
![510(k) Premarket Notification](https://i.imgur.com/6y29Lx7.jpg)
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
Learn more...[1]
References Learn more... (www.fda.gov)
PROWLER INFUSION CATHETER "CORDIS" PROWLER INFUSION CATHETER "CORDIS" “REX” Arm-type Fully Automatic Digital Blood Pressure Monitor “愛力根”娜綺麗音斯蓓拉矽膠乳房植入物 "LOTUS K." DENTAL AMALGAM CAPSULE (NON-STERILE) 甲狀腺抽血報告 tsh正常值 "成春" 一般手術用手動式器械 (未滅菌) "尚鋒" 個人用鉛防護罩(未滅菌) 百 視 美 心電圖 機
保勒注射導管PROWLER INFUSION CATHETER "CORDIS" | 合法醫療器材資訊網
PROWLER INFUSION CATHETER "CORDIS" 台灣衛署醫器輸字第009496號. 保勒注射導管由英商壯生和壯生(香港)股份有限公司臺灣分公司申請,許可證字號: ... Read More
特材收載品項 | 合法醫療器材資訊網
SQL | 合法醫療器材資訊網
CMV016060NCD, "CORDIS"PROWLER INFUSION CATHETER"考迪斯"保勒注射導管※適應症請見備註欄, 606010:606071X, EA, 0, 102/04/01, 090/07/01, N ... Read More
prowler plus catheters | 合法醫療器材資訊網
Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an ... Read More
Cordis Neurovascular | 合法醫療器材資訊網
Cordis Neurovascular, Inc., 14200 NW 57th Ct, Miami Lakes FL 33014-3105. Source ... Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters. Read More
Cordis Continuous Flush Catheter | 合法醫療器材資訊網
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. Manufacturer ... Cordis Neurovascular, Inc., 14200 NW 57th Ct, Miami Lakes FL 33014-3105. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
... PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS. Applicant. CORDIS NEUROVASCULAR, INC. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
ProductCode: KRA Applicant: CORDIS NEUROVASCULAR, INC Decision Date To: 10/09/ ... prowler select (10, 14, and plus) infusion catheters with and without ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
prowler plus infusion catheter17, CORDIS NEUROVASCULAR, INC. K99326618, 10/28/1999. prowler infusion catheters with pre-shaped tips19, CORDIS ... Read More
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【保勒注射導管】許可證字號:衛署醫器輸字第009496號
器材品名:保勒注射導管許可證字號:衛署醫器輸字第009496號註銷狀態:已註銷註銷日期:2012/11/27註銷理由:許可證已逾有效期有...