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ANGIOSYSTEMS, INCORPORATED

US

Last updated May 23, 2026

What ANGIOSYSTEMS, INCORPORATED makes

Angiosystems, Incorporated manufactures medicated surgical procedure kits, single-use and reusable sterile drapes for surgical and angiographic procedures, and radiation shielding materials designed to protect patients from ionizing radiation. Their portfolio includes specialized trays for surgical applications, radiation-shielding pads and drapes, and camera covers for medical imaging equipment.

The company’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. 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 Angiosystems, Incorporated primarily manufacture?

Angiosystems, Incorporated specializes in surgical and radiation protection devices. Their portfolio includes medicated surgical procedure kits, single-use and reusable sterile drapes for general surgery and angiographic procedures, as well as radiation shielding materials like pads, drapes, and camera covers. These products are designed to enhance procedural safety and reduce patient exposure to ionizing radiation during medical imaging.

Where is Angiosystems, Incorporated based?

Angiosystems, Incorporated is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, which govern the design, manufacturing, and distribution of its medical devices.

Which regulatory registries or databases list Angiosystems, Incorporated’s devices?

Angiosystems, Incorporated’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details, compliance, and device history.

How are Angiosystems, Incorporated’s devices classified under FDA regulations?

Angiosystems, Incorporated’s devices fall under three FDA classification categories: Class I (generally low-risk devices requiring minimal regulation), Class II (devices with moderate risk requiring special controls), and Unclassified (U) devices (those not yet assigned a risk category). Classification determines the regulatory pathway and oversight required for each product.

What is the purpose of the radiation shielding materials produced by Angiosystems, Incorporated?

The radiation shielding materials, such as the Halyard Scatter Radiation Shields and patient shielding pads/drapes, are designed to protect patients from ionizing radiation during procedures like fluoroscopy or angiography. These materials absorb or deflect radiation, reducing exposure risks while maintaining procedural visibility for medical staff.

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

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
144884467

Catalogue (336)

Page 6 of 7
DeviceModel / ReferenceRegistriesClassStatus
AngioSystems Tray 5680-11
FDA UDI
Class IActive
Halyard Scatter Radiation Shields 48990 Subclavian Shield Drape L1
FDA UDI
Class IActive
AngioSystems Drape 9360NS
FDA UDI
Class IIActive
AngioSystems Drape 3631-03
FDA UDI
Class IIActive
AngioSystems Drape 3003-27
FDA UDI
Class IIActive
AngioSystems Drape 3644
FDA UDI
Class IIActive
AngioSystems Tray KM5071
FDA UDI
Class IActive
AngioSystems Tray 5670
FDA UDI
Class IActive
AngioSystems Sharp Cup 1036
FDA UDI
Class IIActive
AngioSystems Drape 3432-02S
FDA UDI
Class IIActive
AngioSystems Drape 3001NS
FDA UDI
Class IIActive
AngioSystems Tray KM5056
FDA UDI
Class IActive
AngioSystems Tray KM5022
FDA UDI
Class IActive
AngioSystems Towel 1032-01
FDA UDI
Class IIActive
AngioSystems Drape 3060-08
FDA UDI
Class IIActive
AngioSystems Tray KM5054
FDA UDI
Class IActive
AngioSystems SorbX SX7147
FDA UDI
Class IActive
AngioSystems Drape 3060-5-110
FDA UDI
Class IIActive
AngioSystems Drape KBD0700
FDA UDI
Class IIActive
AngioSystems Tray KM5030
FDA UDI
Class IActive
AngioSystems Drape 3631-10
FDA UDI
Class IIActive
AngioSystems Tray 5702
FDA UDI
Class IActive
AngioSystems Drape 3014-46
FDA UDI
Class IIActive
AngioSystems Cap Cover 6000
FDA UDI
Class IActive
AngioSystems Drape 3270NS
FDA UDI
Class IActive
Halyard Scatter Radiation Shields 49000 Jugular Shield Drape L1 NS
FDA UDI
Class IActive
AngioSystems SorbX SX7253
FDA UDI
Class IActive
AngioSystems SorbX SX8101
FDA UDI
Class IActive
AngioSystems Drape 3307
FDA UDI
Class IIActive
AngioSystems Tray 5681
FDA UDI
Class IActive
AngioSystems Tray KM5035
FDA UDI
Class IActive
AngioSystems Tray 5800
FDA UDI
Class IActive
AngioSystems SorbX SX7140
FDA UDI
Class IActive
AngioSystems Drape 3422NS
FDA UDI
Class IIActive
AngioSystems Drape 3502
FDA UDI
Class IIActive
AngioSystems Drape 3003-21
FDA UDI
Class IIActive
AngioSystems SorbX SX8230
FDA UDI
Class IActive
Halyard Scatter Radiation Shields 49076 Jugular Shield Drape L2
FDA UDI
Class IActive
AngioSystems Tray KM5058
FDA UDI
Class IActive
AngioSystems Tray KM5050
FDA UDI
Class IActive
AngioSystems Tray 5694
FDA UDI
Class IActive
AngioSystems Drape 3021
FDA UDI
Class IIActive
AngioSystems Tray 5621-8
FDA UDI
Class IActive
AngioSystems SorbX SX7251-3
FDA UDI
Class IActive
AngioSystems Drape 3014-5
FDA UDI
Class IIActive
AngioSystems Tray 7015
FDA UDI
Class IActive
AngioSystems Tray 5807
FDA UDI
Class IActive
AngioSystems Drape 3024-31
FDA UDI
Class IIActive
AngioSystems Drape 5020
FDA UDI
Class IActive
AngioSystems SorbX SX8225
FDA UDI
Class IActive

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