DIRECTVISION CATHETER, UNCOATED— 510(k) K110214

Substantially Equivalent

Percuvision

FDA 510(k) clearance K110214 for DIRECTVISION CATHETER, UNCOATED, Substantially Equivalent on 2011-05-27. Applicant: Percuvision.

Clearance details

Applicant: Percuvision
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2011-01-25
Decision date: 2011-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashland, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.