Route 92 Medical Full Length 054 Access System— 510(k) K231583
Substantially EquivalentRoute 92 Medical, Inc.
FDA 510(k) clearance K231583 for Route 92 Medical Full Length 054 Access System, Substantially Equivalent on 2023-08-15. Applicant: Route 92 Medical, Inc..
Clearance details
- Applicant
- Route 92 Medical, Inc.
- Product code
- Code QJP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Mateo, CA, US
Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.