Route 92 Medical Full Length 070 Access System— 510(k) K222743

Substantially Equivalent

Route 92 Medical, Inc.

FDA 510(k) clearance K222743 for Route 92 Medical Full Length 070 Access System, Substantially Equivalent on 2022-10-04. Applicant: Route 92 Medical, Inc..

Clearance details

Applicant: Route 92 Medical, Inc.
Product code: Code QJP
Advisory panel: Cardiovascular
Date received: 2022-09-09
Decision date: 2022-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

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.