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Sign in to claim this brandAngioscore, Inc.
US
Last updated May 23, 2026
What Angioscore, Inc. makes
Angioscore, Inc. manufactures percutaneous transluminal coronary angioplasty (PTCA) scoring balloon catheters designed for coronary artery treatment. These devices are intended for controlled dilation and scoring of atherosclerotic lesions within coronary arteries during angioplasty procedures.
The company’s PTCA scoring balloon catheters are classified as Class II and Class III medical devices under US regulations. They are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, reflecting their regulatory authorisation 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 Angioscore, Inc. manufacture?
Angioscore, Inc. specializes in percutaneous transluminal coronary angioplasty (PTCA) scoring balloon catheters. These devices are specifically designed for coronary artery treatment, enabling controlled dilation and scoring of atherosclerotic plaques during angioplasty procedures. The company’s focus is on coronary angioplasty balloons, which are used to improve blood flow in narrowed or blocked coronary arteries.
Where is Angioscore, Inc. based, and what does that mean for its regulatory oversight?
Angioscore, Inc. is based in the United States. Since it operates within the US market, its devices are subject to regulatory oversight by the FDA. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, indicating they have undergone the necessary regulatory processes for authorisation in the US.
Which regulatory registries list Angioscore, Inc.’s devices, and why does this matter?
Angioscore, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries confirm that the company’s products have met the FDA’s requirements for safety and effectiveness before being authorised for commercial distribution in the US. Listing in these databases helps healthcare providers and regulators verify the legitimacy and regulatory status of the devices.
How are Angioscore, Inc.’s devices classified under US regulations, and what does this classification imply?
Angioscore, Inc.’s PTCA scoring balloon catheters are classified as both Class II and Class III devices under US regulations. Class II devices generally require special controls to ensure their safety and effectiveness, while Class III devices are typically higher-risk and require pre-market approval (PMA) due to insufficient data to establish safety and effectiveness through less rigorous means. The classification reflects the level of scrutiny and regulatory oversight required for these devices.
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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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 615286726
Catalogue (53)
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FDA Recalls (7)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Angioscore, Inc. has seven recall records initiated between November 13, 2007, and November 16, 2010, all of which are recorded as terminated. The reasons cited include mislabeling of product sizes, reports of distal bond failure in scoring elements potentially causing vessel injury or embolism, and separations of the PTCA catheter shaft at the guide wire exit port, which may result in fragments lodging in coronary arteries.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 16, 2010 | Z-0842-2011 | — | terminated | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. |
| Nov 16, 2010 | Z-0839-2011 | — | terminated | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. |
| Nov 16, 2010 | Z-0841-2011 | — | terminated | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. |
| Nov 16, 2010 | Z-0838-2011 | — | terminated | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. |
| Nov 16, 2010 | Z-0840-2011 | — | terminated | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. |
| Dec 4, 2009 | Z-2218-2010 | — | terminated | Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments. |
| Nov 13, 2007 | Z-0591-2008 | — | terminated | Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton |