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# Stroke Device Cleared for Larger Catheters
- URL: https://www.fdaweb.com/stroke-device-cleared-for-larger-catheters/
- Published: 2025-01-27T12:00:00.000Z
- Updated: 2026-09-14T14:51:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158549

FDA has cleared an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters indicated for both access and aspiration when used with a Zoom Catheter. The clearance expands Imperative Care’s current offering of .035” to .071” aspiration catheters, the company says.

The clearance is based on clinical evidence submitted from the company’s [Imperative Trial](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT04129125%3Fterm%3DImperative%2520Care%26rank%3D1&esheet=54189461&newsitemid=20250127916480&lan=en-US&anchor=Imperative+Trial&index=3&md5=6180eb1d1a7efe9b2777d84ab21c516d&ref=fdaweb.com) which reportedly demonstrated median time from groin puncture to successful reperfusion of 19 minutes, successful reperfusion in 84% of patients within three passes or less without the use of additional thrombectomy devices as rescue therapy, and stent retriever rescue therapy used in 4.7% of cases.