K242672 is an FDA 510(k) clearance for the Zoom System. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.
Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on January 14, 2025 after a review of 130 days - within the typical 510(k) review window.
This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.
View all Imperative Care, Inc. devices
NCT04129125
Completed
Interventional
Industry-sponsored
The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
A Prospective, Multi-center, Open Label and Single Arm Clinical Investigation to Evaluate the Safety and Efficacy of Using the Zoom Reperfusion System in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients
| Condition studied |
Ischemic Stroke; Acute Stroke |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Raul G Nogueira, MD |
| Sponsor |
Imperative Care, Inc.
(industry)
|
Started 2021-10-01
→
Primary completion 2024-05-28
Primary outcome
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success
Secondary outcome
ITT Cohort: Time to Achieve mTICI Score ≥ 2b
View full study on ClinicalTrials.gov