ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter— 510(k) K221414

Substantially Equivalent

Silk Road Medical, Inc.

FDA 510(k) clearance K221414 for ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter, Substantially Equivalent on 2022-09-02. Applicant: Silk Road Medical, Inc..

Clearance details

Applicant: Silk Road Medical, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2022-05-16
Decision date: 2022-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.