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Sign in to claim this brandANGIOSYSTEMS, 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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- 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 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AngioSystems SorbX | SX8200 | FDA UDI | Class I | Active |
| AngioSystems Tray | KM5043 | FDA UDI | Class I | Active |
| AngioSystems Tray | 5550 | FDA UDI | Class I | Active |
| AngioSystems Tray | 5686-11 | FDA UDI | Class I | Active |
| AngioSystems Tray | KM5061-1 | FDA UDI | Class I | Active |
| AngioSystems Tray | 5703 | FDA UDI | Class I | Active |
| AngioSystems Tray | KM5075 | FDA UDI | Class I | Active |
| AngioSystems Drape | 9009-01 | FDA UDI | Class II | Active |
| AngioSystems Tray | KM5014 | FDA UDI | Class I | Active |
| AngioSystems Drape | 9260-10 | FDA UDI | Class II | Active |
| AngioSystems Tray | 1056-1 | FDA UDI | Class I | Active |
| AngioSystems Drape | 3014 | FDA UDI | Class II | Active |
| AngioSystems Tray | KM5067 | FDA UDI | Class I | Active |
| AngioSystems SorbX | SX8110 | FDA UDI | Class I | Active |
| Halyard Scatter Radiation Shields | 49035 Peripheral Shield Drape L1 | FDA UDI | Class I | Active |
| AngioSystems SorbX | SX7270 | FDA UDI | Class I | Active |
| Halyard Scatter Radiation Shields | 49038 Multi-Purpose Shield Drape W/ FEN L2 NS | FDA UDI | Class I | Active |
| Halyard Scatter Radiation Shields | 48958 Multi Purpose Shield L1 | FDA UDI | Class I | Active |
| AngioSystems Tray | 7025-1 | FDA UDI | Class I | Active |
| AngioSystems Drape | ASD3330-1 | FDA UDI | Class II | Active |
| AngioSystems Drape | 3631-20NS | FDA UDI | Class II | Active |
| AngioSystems Drape | 3270 | FDA UDI | Class I | Active |
| AngioSystems Drape | 3427 | FDA UDI | Class II | Active |
| AngioSystems SorbX | SX7100 | FDA UDI | Class I | Active |
| Halyard Scatter Radiation Shields | 49070 Biopsy Shield Drape L2 | FDA UDI | Class I | Active |
| AngioSystems Tray | 5021-2 | FDA UDI | Class I | Active |
| AngioSystems Drape | 3203-05 | FDA UDI | Class II | Active |
| AngioSystems SorbX | SX8107 | FDA UDI | Class I | Active |
| Halyard Scatter Radiation Shields | 49071 Angiography Shield Drape L2 NS | FDA UDI | Class I | Active |
| AngioSystems Tray | KM5052 | FDA UDI | Class I | Active |
| Halyard Scatter Radiation Shields | 48988 Angiography Shield Drape L1 | FDA UDI | Class I | Active |
| AngioSystems Tray | KM5069 | FDA UDI | Class I | Active |
| AngioSystems Tray | KM5055 | FDA UDI | Class I | Active |
| AngioSystems SorbX | SX7256 | FDA UDI | Class I | Active |
| AngioSystems Drape | 3060-5 | FDA UDI | Class II | Active |
| AngioSystems Drape | 3671 | FDA UDI | Class II | Active |
| AngioSystems SorbX | SX8201 | FDA UDI | Class I | Active |
| AngioSystems Tray | KM5017 | FDA UDI | Class I | Active |
| AngioSystems Tray | KM5063 | FDA UDI | Class I | Active |
| AngioSystems Drape | 3014-42 | FDA UDI | Class II | Active |
| AngioSystems Drape | 3044 | FDA UDI | Class II | Active |
| AngioSystems Tray | KM5066 | FDA UDI | Class I | Active |
| AngioSystems Drape | 3681 | FDA UDI | Class II | Active |
| AngioSystems Tray | KM5032-5 | FDA UDI | Class I | Active |
| AngioSystems SorbX | SX8300 | FDA UDI | Class I | Active |
| Halyard Scatter Radiation Shields | 49016 Jugular Shield Drape L1 | FDA UDI | Class I | Active |
| AngioSystems Tray | 7020-2 | FDA UDI | Class I | Active |
| AngioSystems Drape | ASD2111 | FDA UDI | Class II | Active |
| AngioSystems Drape | 3902 | FDA UDI | Class II | Active |
| AngioSystems Tray | 5602-8 | FDA UDI | Class I | Active |
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