K243601 is an FDA 510(k) clearance for the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.
Submitted by Route 92 Medical, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 19, 2025 after a review of 179 days - an extended review cycle.
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 Route 92 Medical, Inc. devices
NCT05018650
Completed
Interventional
Industry-sponsored
A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)
A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients (SUMMIT MAX)
| Condition studied |
Acute Ischemic Stroke |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Guilherme Dabus, MD |
| Sponsor |
Route 92 Medical, Inc.
(industry)
|
Started 2021-12-21
→
Primary completion 2024-02-19
→
Completed 2024-05-22
Primary outcome
Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater
Study completed - no results published.
This trial concluded in 2024 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov