MODIFICATION TO GELBFISH VASCULAR DILATORS— 510(k) K023507

Substantially Equivalent

Vascumetrix, LLC

FDA 510(k) clearance K023507 for MODIFICATION TO GELBFISH VASCULAR DILATORS, Substantially Equivalent on 2002-11-08. Applicant: Vascumetrix, LLC.

Clearance details

Applicant: Vascumetrix, LLC
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2002-10-18
Decision date: 2002-11-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Mesa, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.