Acs Et Hi-Flow/Enhanced Torque Coronary Guid Cath
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K926421 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Acs Et Hi-Flow/Enhanced Torque Coronary Guid Cath is a coronary guid catheter. It is designed to provide high flow and enhanced torque during coronary procedures.
The device is supplied as a single-use product and is classified as a Class II medical device. It has been cleared by the FDA via the 510(k) pathway, with clearance number K926421. The device is manufactured by Advanced Cardiovascular Systems, Inc.
Frequently asked questions
What is the ACS ET Hi-Flow Coronary Guid Cath used for?
The ACS ET Hi-Flow Coronary Guid Cath is used for coronary procedures, providing high flow and enhanced torque.
Is the ACS ET Hi-Flow Coronary Guid Cath reusable?
No, the ACS ET Hi-Flow Coronary Guid Cath is supplied as a single-use product.
What is the regulatory status of the ACS ET Hi-Flow Coronary Guid Cath?
The device has been cleared by the FDA via the 510(k) pathway, with clearance number K926421.
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: ACS ET Hi-Flow Enhanced Torque Coronary Guid Cath - Advanced ..., Acs Et Hi-flow/Enhanced Torque Coronary Guid Cath, ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH… - FDA.report, K926421 - Acs Et Hi-flow/Enhanced Torque Coronary Guid Cath, PDF K926421 - Acs Et Hi-flow/Enhanced Torque Coronary Guid Cath
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K926421 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K926421 24 fields · synced Sep 25, 2026