K210635
Substantially EquivalentRoute 92 Medical Full Length 088 Access System
- Applicant
- Route 92 Medical, Inc.
- Product 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.