510(k) Premarket Notification | 合法醫療器材資訊網
castor,achillesandhermesncptaballoondilatationcatheter17,BrosmedMedicalCo.,Ltd.K16094118,12/13/2016.polux,minervaandatroposptaballoon ...
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.
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References Learn more... (www.fda.gov)
“Brosmed” Hermes NC PTA Balloon Dilatation Catheter “Brosmed” Hermes NC PTA Balloon Dilatation Catheter 瑪可朵散光軟式隱形眼鏡 opto engineering singapore MBL ENA TEST “日本光電” 血液學品管液 sl-120 technics “UNIMAX”Tracheobronchial suction catheter (Sterile) Nc trek coronary dilatation catheter 超高速離心管
PTA catheter - Hermes™ NC | 合法醫療器材資訊網
Hermes™ NC PTA Balloon Cathéter Non-Compliant 0.035 OTW Engineered for AV Access Nominal Pressure:1 2atm Rated Burst Pressure(RBP):22atm(03.O-4. Read More
PTA catheter - Achilles™ NC | 合法醫療器材資訊網
Achilles™ PTA Balloon Catheter Non-Compliant 0.018 OTW Excellent for dilatation and lesion preparation •Nominal Pressure:12atm •Rated Burst ... Read More
Hermes NC | 合法醫療器材資訊網
Hermes NC. 0.035'' OTW PTA Balloon Dilatation Catheter. Download Brochure. About Us. About BrosMed · Quality & Compliance · Awards & Events. Read More
BrosMed Announces FDA 510(k) Clearance and Launch of ... | 合法醫療器材資訊網
2016年12月14日 — ... and Launch of Hermes™ NC 0.035 OTW PTA, Achilles™ NC 0.018 OTW PTA and Castor™ NC 0.014 OTW PTA Balloon Dilatation Catheters. Read More
BrosMed Medical Co. | 合法醫療器材資訊網
2020年2月19日 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter achieves ... PTA, Minerva™ 0.018 PTA, Polux™ 0.014 PTA, Hermes™ NC 0.035 PTA, ... Read More
BrosMed obtained CE certificate for Interventional Accessories ... | 合法醫療器材資訊網
2020年6月5日 — May 27th, 2020—BrosMed Medical Co., Ltd. announced that the CE and ISO ... Hermes™ NC 0.035 PTA Balloon Dilatation Catheter. Read More
Class 2 Device Recall Hermes NC PTA Balloon Dilation ... | 合法醫療器材資訊網
2019年2月27日 — The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
castor, achilles and hermes nc pta balloon dilatation catheter17, Brosmed Medical Co., Ltd. K16094118, 12/13/2016. polux , minerva and atropos pta balloon ... Read More
BrosMed Medical Co. | 合法醫療器材資訊網
2020年2月19日 — “Wedge NC Scoring Balloon Dilatation Catheter was ideally ... 0.035 PTA, Minerva™ 0.018 PTA, Polux™ 0.014 PTA, Hermes™ NC 0.035 PTA, ... Read More
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