K243601

Substantially Equivalent

Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

Applicant: Route 92 Medical, Inc.
Product code: NRY
Advisory panel: Cardiovascular
Date received: 2024-11-21
Decision date: 2025-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.