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Sign in to claim this brandReverse Medical Corporation
US
Last updated May 30, 2026
What Reverse Medical Corporation makes
Reverse Medical Corporation manufactures single-use vascular guide-catheters and microvascular plug systems designed for interventional procedures. Their portfolio includes microcatheters, guide catheter systems, and balloon guide catheters tailored for precise vascular access and embolization. The company also produces systems for reporting and vascular plugging in microvascular applications.
The devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer operates from the United States, adhering to applicable US regulatory requirements for medical devices.
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 Reverse Medical Corporation primarily manufacture?
Reverse Medical Corporation specializes in single-use vascular guide-catheters and microvascular plug systems. Their portfolio includes microcatheters, guide catheter systems, balloon guide catheters, and embolization tools designed for interventional procedures. These devices are tailored for precise vascular access and microvascular applications, ensuring targeted delivery and control during medical interventions.
Where is Reverse Medical Corporation based, and how does this affect its regulatory compliance?
Reverse Medical Corporation is based in the United States. As a US-based manufacturer, its devices must comply with the applicable regulatory requirements set by the FDA, including classification under the agency’s risk-based system. The company’s location ensures alignment with US regulatory standards, which govern the design, manufacturing, and distribution of its medical devices.
How are the devices manufactured by Reverse Medical Corporation classified under US regulations?
The devices produced by Reverse Medical Corporation are classified as Class II under the US FDA’s regulatory framework. This classification indicates a moderate level of risk, requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices typically undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory databases list the devices manufactured by Reverse Medical Corporation?
The devices from Reverse Medical Corporation are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. The 510(k) database tracks premarket submissions for Class II devices, while the UDI system ensures standardized identification and traceability of medical devices throughout their lifecycle. These listings help healthcare providers and regulators verify compliance and device details.
What is the primary purpose of the microvascular plug systems and guide catheters produced by Reverse Medical Corporation?
The microvascular plug systems and guide catheters from Reverse Medical Corporation are designed for interventional radiology and vascular procedures, including embolization and precise vascular access. The microvascular plug systems (e.g., MVP) are used to occlude small blood vessels, while the guide catheters (e.g., microcatheters and balloon guide catheters) provide controlled access and delivery pathways for interventions in complex vascular anatomy. Their single-use design ensures sterility and reduces infection risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- medtronic.com
- —
- —
- [email protected]
- Phone
- +1(800)633-8766
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 963324913
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mvp® | MVP-3US | FDA UDI | Class II | Unknown |
| ReverseTM | MIC-021-150 | FDA UDI | Class II | Active |
| Mvp® | MVP-7Q | FDA UDI | Class II | Unknown |
| Mvp® | MVP-9Q | FDA UDI | Class II | Unknown |
| Mvp® | MVP-5US | FDA UDI | Class II | Unknown |
| ReverseTM | MIC-027-150 | FDA UDI | Class II | Active |
| ReverseTM | MIC-021-150 | FDA UDI | Class II | Active |
| Recruit Microcatheter | K091563 | FDA 510(k) | Class II | Active |
| Reverse Medical Report Guide Catheter System | K102418 | FDA 510(k) | Class II | Active |
| Reverse Medical Micro Vascular Plug (mvp) System | K133282 | FDA 510(k) | Class II | Active |
| Reverse Medical Micro Vascular Plug System | K150108 | FDA 510(k) | Class II | Active |
| Reverse Medical Micro Vascular Plug (mvp) System | K123803 | FDA 510(k) | Class II | Active |
| Reflex Ballon Guide Catheter | K112262 | FDA 510(k) | Class II | Active |
| Reverse Medical Micro Vascular Plug System | K141313 | FDA 510(k) | Class II | Active |
| Reverse Medical Reflex Guide Catheter | K110055 | FDA 510(k) | Class II | Active |
| Reverse Medical Microcatheter | K130858 | FDA 510(k) | Class II | Active |
| Reverse Medical Microcatheter | K122684 | FDA 510(k) | Class II | Active |
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