Imperative care zoom catheter 510k

Author: upuf

August undefined, 2024

Witryna6 paź 2024 · Imperative Care is recalling ZOOM 71 Reperfusion Catheter, used to remove blood clots in the brain, due to risk of breaking during use. WitrynaImperative Care Inc. K180169 D. Device Description: The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP, Zoom™ 88 LDP and Zoom™ …

Imperative Care, Inc. Teri Nguyen Senior Regulatory Affairs Specialist

WitrynaSpecial 510(k) is the prior generation of ZOOM Reperfusion Catheter and Aspiration Tubing cleared under 510(k) K202482 with the same device names. Table 3 … WitrynaZoom Stroke Solution™ Aim for TICI 3 in 10 minutes. We know that time is brain. So we engineered the Zoom Stroke Solution as a complete system — from access through … chipwrecked brittany miller flower dress

Careers - Imperative Care

WitrynaCommon Name: Embolectomy Catheter Classification: Catheter, Embolectomy (21 CFR 870.5150, Product Code: QEW) Predicate Devices . 880 Medical, LLC WOLF Thrombectomy Device (K182835) (Primary) Reference Device . Edwards LifeSciences Fogarty Venous Thrombectomy Catheter (510K number unknown) Description Witryna4 sty 2024 · The FDA has granted 510 (k) clearance to Imperative Care’s Zoom RDL Access System, making it the first radial access platform developed specifically for treating patients with ischemic stroke. Additionally, the company also announced the successful completion of the first-in-human case using Zoom RDL. WitrynaImperative Care, Inc. 1359 Dell Avenue Campbell CA 95008 U.S.A. +1 -408 -502 -7548 ZoomTM Aspiration Catheters (Zoom 71, Zoom 55, Zoom 45, Zoom 35) See IFU … chipwrecked air alvin

Imperative Care, Inc. Kristin Ellis Regulatory Affairs Manager

Imperative Care Announces First Patient Enrolled in the Imperative ...

WitrynaDevice Classification Name: catheter, percutaneous, neurovasculature: 510(k) Number: K220807: Device Name: Imperative Care Radial 088 Access System: Applicant Witryna2 maj 2024 · Medical technology company Imperative Care has received 510 (k) clearance from the US Food and Drug Administration (FDA) for the use of its Zoom … chipwreckedblurayWitrynaHerein, we provide our initial experience with the intracranial navigation of a large-bore (.088" inner diameter) catheters during mechanical thrombectomy (MT). Methods: Retrospective review of consecutive large vessel occlusion stroke patients in whom a TracStar™ or Zoom 88™ (Imperative Care, Campbell, CA) large-bore catheters … chipwrecked animal

"WitrynaCatheter Length (cm) Imperative Care. Zoom 35 Aspiration Catheter. Neurovascular aspiration catheter with angled TRX Tip; single lumen, braid and coil reinforced, variable stiffness catheter with a radiopaque marker and a lubricious hydrophilic coating. Distal OD: 1.30 mm; ID: 0.035 inch. 6. " - Imperative care zoom catheter 510k

Imperative care zoom catheter 510k

Witryna© 2024 Imperative Care IMPERATIVE CARE, LDP and TRACSTAR are registered trademarks and ADVANCED FIBER TECHNOLOGY, ELEVATING STROKE CARE, … Witrynacatheter, thrombus retriever. 22. 510 (k) Number. K202482. Device Name. ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing. Applicant. Imperative …

Did you know?

WitrynaZoom Aspiration Catheters are built to work together, enabling effortless navigation and uncompromised structural integrity across the full Zoom Stroke Solution portfolio. 4 … WitrynaJoin us and help change the future of stroke care! The impact Imperative Care is making on the entire continuum of stroke care is a testament to the team. It is a privilege to collaborate and learn from them, all while elevating the quality of life of patients.

WitrynaDevice Classification Name. catheter, percutaneous, neurovasculature. 22. 510 (k) Number. K203764. Device Name. TracStar Large Distal Platform, ZOOM 88 Large … WitrynaImperative Care - Next Generation Stroke Technology Get Closer to Clot with Zoom™ 88 Take a large-bore access catheter farther than ever before — and get to a …

Witryna100% visual inspection was performed on the distal section of the catheter and the distal section was free of defects or protrusions. The root cause of the detachment is unable … Witryna4 paź 2024 · October 4, 2024—Imperative Care, Inc. announced that the first patient has been enrolled in the prospective, multicenter IMPERATIVE clinical trial, which will enroll 262 patients at up to 30 sites in the United States. The trial is designed to evaluate the clinical benefits of direct aspiration using the company’s Zoom 88 large distal platform …

WitrynaImperative Care is dedicated to the continued generation of robust clinical research evidence in support of better care for stroke patients. We believe that the current evidence, as well as the anticipated future studies we are planning, will assist physicians in selecting the most appropriate treatment for their patients.

Witryna4 paź 2024 · Imperative Care is a medical technology company focused on developing the next generation of innovative solutions to address the vast and urgent needs in stroke. The company has two 510 (k)... chipwrecked big city greensWitrynaThe SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic … graphic design alternative interfaces graphic design americus gaWitrynaThe Zoom Aspiration Tubing Set is intended to connect the Zoom Aspiration Catheter to the Zoom Canister of the Zoom Aspiration Pump and to allow the user to control the … chipwrecked brittanyWitryna18 sie 2024 · © 2024 Imperative Care IMPERATIVE CARE, LDP and TRACSTAR are registered trademarks and ADVANCED FIBER TECHNOLOGY, ELEVATING … chipwrecked creditsWitrynaThe ZOOM Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature … graphic design aidsWitryna22 gru 2024 · Catalog Number: ICTC088110 Company Name: IMPERATIVE CARE, INC. Primary DI Number: 00812212030177 Issuing Agency: GS1 Commercial Distribution … graphic design american symbols