CoraForce Microcatheter, CoraFlex Microcatheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251277 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 CoraForce Microcatheter and CoraFlex Microcatheter are torqueable coronary microcatheters designed for navigation, support, and guidewire exchange in complex cases. They are used in cardiovascular procedures, specifically in complex coronary interventions. The microcatheters are designed to provide support and facilitate guidewire exchange. They are part of a line of microcatheters for complex percutaneous coronary interventions (PCI).
The CoraForce and CoraFlex Microcatheters are supplied by Reflow Medical, Inc. and have been found substantially equivalent by the FDA. They have a product code of DQY and have been assigned the k number K251277. The devices are intended for use in cardiovascular settings and are designed for complex coronary interventions.
Frequently asked questions
What are the CoraForce and CoraFlex Microcatheters used for?
They are used in cardiovascular procedures, specifically for navigation, support, and guidewire exchange in complex coronary interventions.
Are the CoraForce and CoraFlex Microcatheters supplied sterile?
The description does not explicitly state sterility, but they are designed for use in cardiovascular settings, implying proper sterilization procedures would be followed.
What is the regulatory status of the CoraForce and CoraFlex Microcatheters?
The devices have been found substantially equivalent by the FDA and have been assigned the k number K251277, indicating a Special 510K clearance.
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: Cora Torqueable Microcatheters | US | Reflow Medical, Reflow Medical Announces U.S. Launch of Next-Generation Cora Flex, Reflow Medical Announces U.S. Launch of Next-Generation Cora Flex, Reflow Launches CoraCatheters Line of Microcatheters for Complex PCI
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251277 | Class II | Active |
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Manufacturer
- Manufacturer
- Reflow Medical, Inc.
Sources (1)
- FDA 510(k) K251277 24 fields · synced Oct 6, 2026