Route 92 Medical 088 Access System— 510(k) K201518
Substantially EquivalentRoute 92 Medical
FDA 510(k) clearance K201518 for Route 92 Medical 088 Access System, Substantially Equivalent on 2020-08-14. Applicant: Route 92 Medical.
Clearance details
- Applicant
- Route 92 Medical
- Product code
- Code QJP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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.