Vention Costa Rica S.A.

⚠️ Moderate Risk

FEI: 3009792018 • Heredia, Heredia • COSTA RICA

FEI

FEI Number

3009792018

📍

Location

Heredia, Heredia

🇨🇷

Country

COSTA RICA

🏢

Address

Zona Franca Metropolitana, , Heredia, Heredia, Costa Rica

Moderate Risk

FDA Import Risk Assessment

48.9

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

7/19/2017

Latest Refusal

7/19/2017

Earliest Refusal

Score Breakdown

Violation Severity

60.0×40%

Refusal Volume

49.7×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

11821×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

50821×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2017	74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Vention Costa Rica S.A.'s FDA import refusal history?

Vention Costa Rica S.A. (FEI: 3009792018) has 21 FDA import refusal record(s) in our database, spanning from 7/19/2017 to 7/19/2017.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Vention Costa Rica S.A.'s FEI number is 3009792018.

What types of violations has Vention Costa Rica S.A. received?

Vention Costa Rica S.A. has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Vention Costa Rica S.A. come from?

All FDA import refusal data for Vention Costa Rica S.A. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.