Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland
Description du dispositif
Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA || Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
US Distribution to states of: CA, IN, PA, AL, and NJ.
Description du dispositif
Trevo Pro 4 Stent Retriever, || Model number 80021; || U.S. Indications for use: The Trevo Retriever is intended to restore blood || flow in the neurovasculature by removing thrombus in patients experiencing || ischemic stroke within 8 hours of symptom onset. Patients who are ineligible || for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA || therapy are candidates for treatment.
US Distribution including the states of PA, CA, TX, NM, and OH.
Description du dispositif
Merci Retriever || Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
US (nationwide) including the states of CA, FL, GA, OR and TN.
Description du dispositif
FlowGate Balloon Guide Catheter; || Manufactured by Concentric Medical, Mountain View, CA. || FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014
US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
Description du dispositif
Distal Access Catheter: || Model Numbers: 90121, 90130, 90131, 90160. || The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.