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Bluegrass Vascular Technologies, Inc.

United States·US-MF-000033718

Last updated September 18, 2026

About

Merit Medical Systems, Inc. is a global medical device company dedicated to the diagnosis and treatment of cardiovascular, endoscopy, oncology, peripheral intervention, and critical care conditions.

From the manufacturer's own website. Source

What Bluegrass Vascular Technologies, Inc. makes

Bluegrass Vascular Technologies, Inc. manufactures central venous catheter inside-out introduction sets, including the Surfacer Inside-Out Access Catheter System. These devices are designed to facilitate vascular access procedures by enabling catheter insertion from within an existing venous line.

The company’s products fall under FDA Class II regulation and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Bluegrass Vascular Technologies, Inc. manufacture?

Bluegrass Vascular Technologies, Inc. specializes in central venous catheter inside-out introduction sets. These devices are specifically designed to allow catheter insertion through an existing venous line, simplifying vascular access procedures. The most commonly listed device in regulatory databases is the Surfacer Inside-Out Access Catheter System.

Where is Bluegrass Vascular Technologies, Inc. based?

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory listings confirm it operates within the U.S., aligning with FDA oversight.

Which regulatory registries list Bluegrass Vascular Technologies, Inc.’s devices?

Bluegrass Vascular Technologies, Inc.’s devices are included in the FDA’s 510(k) pre-market notification database and the Unique Device Identifier (UDI) system. These registries track Class II devices like theirs, ensuring traceability and compliance with U.S. medical device regulations.

How are Bluegrass Vascular Technologies, Inc.’s devices classified by regulatory authorities?

The company’s devices fall under FDA Class II classification. This category applies to products that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as the Surfacer Inside-Out Access Catheter System.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
12500, Network Blvd, San Antonio, United States
Phone
+1 210 558 0819
PRRC Contact
Gabriele Niederauer
EUDAMED SRN
US-MF-000033718
FDA FEI Number
—
DUNS Number
080441650

Catalogue (2)

DeviceModel / ReferenceRegistriesClassStatus
Surfacer Inside-Out Access Catheter System 600200/A
FDA UDI
Class IIActive
Surfacer Inside-Out Access Catheter System DEN190038
FDA 510(k)
Class IIActive

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