Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set— 510(k) K243601
Substantially EquivalentRoute 92 Medical, Inc.
FDA 510(k) clearance K243601 for Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, Substantially Equivalent on 2025-05-19. Applicant: Route 92 Medical, Inc..
Clearance details
- Applicant
- Route 92 Medical, Inc.
- Product code
- Code NRY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, through . 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.