WebDate Received: 04/12/2024: Decision Date: 06/11/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel WebFG15150-0615-1S: ev3 Cathera Phenom 027 Catheter, StraightIn-Date » Medtronic Vascular » Micro Catheters. FG15150-0615-1S: ev3 Cathera Phenom 027 Catheter, Straight. Photos are for illustration purposes only …
Medtronic launches Solitaire X and Phenom 21 …
WebTracker® Infusion Catheter (510k # K862117) Device Description: The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. Websteel shaping mandrel to shape the distal portion of the catheter. V. INDICATIONS FOR USE. Subject Device Predicate K213451 K151638 The Spartan MC 0165™ is intended for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral and coronary vasculatures. The Phenom Catheters are intended for the deca i kozije mleko
510(k) Premarket Notification - Food and Drug Administration
WebEvent Description. It was reported that: "prep: right radial with 071 7f rist catheter, phenom plus and sl10 // right femoral with 7f infinity sheath, phenom plus and phenon 17. Diagnostic angiograms of of right and left ica, mca and aca were performed to get better and more recent views of anatomy to measure vessel diameter, aneurysm neck ... WebPHENOM™* 017 CATHETER Product Catalog Number Soft Distal Segment (cm) Proximal Outer Diameter (in) Distal Outer Diameter (in) Catheter Inner Diameter (in) FG13150-0615-2S 6 0.034 0.030 0.021 FG13150-1015-2S 10 0.034 0.030 0.021 PHENOM™* 021 CATHETER Product Catalog Number Flexible Single Coil Length (cm) Proximal Outer Diameter (in) … WebMay 1, 2024 · I find that Solitaire X 6×40 device combined with Phenom 21 catheter provides smooth navigation especially when working with complicated anatomy.” Stroke is the second leading cause of death … bcc nundah library