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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 5 of 7
DeviceModel / ReferenceRegistriesClassStatus
AngioSystems Drape 3000-06
FDA UDI
Class IIActive
Halyard Scatter Radiation Shields 49037 Multi-Purpose Shield Drape L2
FDA UDI
Class IActive
AngioSystems Drape 5073
FDA UDI
Class IActive
AngioSystems Tray KM5045
FDA UDI
Class IActive
AngioSystems Drape 3028-18
FDA UDI
Class IIActive
AngioSystems Drape 3572
FDA UDI
Class IIActive
Halyard Scatter Radiation Shields 49017 Biliary Shield Drape L1 NS
FDA UDI
Class IActive
Halyard Scatter Radiation Shields 48989 Subclavian Shield Drape L1 NS
FDA UDI
Class IActive
Halyard Scatter Radiation Shields 48987 Angiography Shield Drape L1 NS
FDA UDI
Class IActive
AngioSystems SorbX SX8161
FDA UDI
Class IActive
AngioSystems Towel SB017026
FDA UDI
Class IIActive
AngioSystems Tray 5805
FDA UDI
Class IActive
AngioSystems Tray 5048-7
FDA UDI
Class IActive
AngioSystems Tray 7026
FDA UDI
Class IActive
AngioSystems Drape 3528
FDA UDI
Class IIActive
AngioSystems SorbX SX7200
FDA UDI
Class IActive
AngioSystems Tray 7010
FDA UDI
Class IActive
AngioSystems Drape 3015-1
FDA UDI
Class IIActive
Angiosystems Drape 3217NS
FDA UDI
Class IIActive
Halyard Scatter Radiation Shields 49079 Peripheral Shield Drape L2 NS
FDA UDI
Class IActive
AngioSystems SorbX SX7156
FDA UDI
Class IActive
AngioSystems Tray 5671
FDA UDI
Class IActive
AngioSystems SorbX SX7246
FDA UDI
Class IActive
AngioSystems Drape 3241NS
FDA UDI
Class IIActive
AngioSystems Tray KM5072
FDA UDI
Class IActive
AngioSystems Drape 9260-12
FDA UDI
Class IIActive
AngioSystems Drape KBD2545-4NS
FDA UDI
Class IIActive
AngioSystems Tray KM5068
FDA UDI
Class IActive
AngioSystems Tray 5634
FDA UDI
Class IActive
AngioSystems Drape 9009-01NS
FDA UDI
Class IIActive
AngioSystems Tray 7021
FDA UDI
Class IActive
AngioSystems Tray 1055
FDA UDI
Class IActive
AngioSystems Tray 1000
FDA UDI
Class IActive
Halyard Scatter Radiation Shields 49078 Biliary Shield Drape L2
FDA UDI
Class IActive
AngioSystems Drape 3003-45
FDA UDI
Class IIActive
AngioSystems SorbX SX8226
FDA UDI
Class IActive
AngioSystems Drape 3003-26
FDA UDI
Class IIActive
AngioSystems Drape 6000
FDA UDI
Class IIActive
AngioSystems Drape 3670
FDA UDI
Class IIActive
AngioSystems Tray 5745
FDA UDI
Class IActive
AngioSystems SorbX SX7120
FDA UDI
Class IActive
AngioSystems SorbX SX7144
FDA UDI
Class IActive
AngioSystems SorbX SX8126
FDA UDI
Class IActive
AngioSystems Tray 5713
FDA UDI
Class IActive
AngioSystems SorbX SX8270
FDA UDI
Class IActive
AngioSystems Drape 3665-1
FDA UDI
Class IIActive
AngioSystems Tray 5559
FDA UDI
Class IActive
AngioSystems Tray 5743-5
FDA UDI
Class IActive
AngioSystems Drape 3003-37
FDA UDI
Class IIActive
Angiosystems inc sx8200 case
FDA UDI
Class IActive

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