USCI Angiographic Balloon Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K831854 FDA 510(k)
- FDA Product Code
- DYG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1240 FDA 510(k)
- Regulation Number
- 870.1240 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The USCI Angiographic Balloon Catheter is a flow-directed catheter used in cardiovascular procedures. It is designed for angiographic applications, allowing for visualization and intervention within the vascular system.
This device is supplied as a single-use or reusable product, depending on the specific model. It is regulated under FDA 510(k) clearance with product code DYG and is classified as a Class 2 cardiovascular device. The device is available in various sizes and models, including K831854, and is manufactured by C.R. Bard, Inc.
Frequently asked questions
What is the USCI Angiographic Balloon Catheter used for?
The USCI Angiographic Balloon Catheter is a flow-directed catheter designed for angiographic applications in cardiovascular procedures. It allows for visualization and intervention within the vascular system, helping clinicians diagnose and treat various cardiovascular conditions.
Is the USCI Angiographic Balloon Catheter single-use or reusable?
The USCI Angiographic Balloon Catheter is supplied as either a single-use or reusable product, depending on the specific model selected. This flexibility allows healthcare facilities to choose the option that best fits their clinical needs and infection control protocols.
What sizes and models of the USCI Angiographic Balloon Catheter are available?
The device is available in various sizes and models to accommodate different clinical applications. One specific model referenced is K831854, though the complete range of sizes and configurations isn't detailed in the available information.
What is the regulatory classification of the USCI Angiographic Balloon Catheter?
The USCI Angiographic Balloon Catheter is regulated under FDA 510(k) clearance with product code DYG and is classified as a Class 2 cardiovascular device. This classification indicates it has moderate risk and requires special controls to ensure its safety and effectiveness.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: USCI ANGIOGRAPHIC BALLOON CATHETER (K831854) - FDA 510 (k), Usci Angiographic Balloon Catheter 510(k) K831854 - FDA.report, K932092 FDA 510 (k) - USCI ANGIOGRAPHIC CATHETER, Usci Angiographic Catheter 510 (k) FDA Premarket Notification K932092 C ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831854 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K831854 24 fields · synced Sep 26, 2026