COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105— 510(k) K983411

Substantially Equivalent

Valnet Medical Corp.

FDA 510(k) clearance K983411 for COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105, Substantially Equivalent on 1999-02-09. Applicant: Valnet Medical Corp..

Clearance details

Applicant: Valnet Medical Corp.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1998-09-28
Decision date: 1999-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Isabel, PR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.