Site Seal SV— 510(k) K190351

Substantially Equivalent

Ensite Vascular

FDA 510(k) clearance K190351 for Site Seal SV, Substantially Equivalent on 2019-07-02. Applicant: Ensite Vascular.

Clearance details

Applicant: Ensite Vascular
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2019-02-14
Decision date: 2019-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Olathe, KS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.