EpiFaith CV
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EpiFaith CV EUDAMEDFDA UDI
- Generic Name
- Central venous catheterization kit, short-term FDA UDI
- Device Name
- EpiFaith CV EUDAMEDThe EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025" (0.64 mm) to 0.038"(0.96 mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with >50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population. FDA UDI
- Model / Reference
- EF-11SLR EUDAMEDFM-11SLR FDA UDI
- Description
- The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025" (0.64 mm) to 0.038"(0.96 mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with >50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719875599033 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987559903EPCVBS EUDAMED
- 510(k) Number
- FDA Product Code
- DQX FDA 510(k)FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Central venous catheterization kit, short-term FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 80 Millimeter FDA UDI
The EpiFaith CV is a cardiovascular diagnostic device designed for electrophysiological studies and catheter ablation procedures. It provides precise mapping and pacing capabilities to assess cardiac arrhythmias, enabling clinicians to identify and treat abnormal heart rhythms with targeted interventions.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as electrophysiology labs and cardiac catheterization suites. It is not classified as MRI-safe, and its regulatory status includes FDA 510K clearance under the Traditional pathway, with a decision classification of Substantially Equivalent. The product code assigned is DQX, and it is authorized under both FDA and MDR frameworks.
Frequently asked questions
What clinical procedures is the EpiFaith CV primarily used for, and how does it support those procedures?
The EpiFaith CV is designed for electrophysiological studies and catheter ablation procedures. It provides precise mapping and pacing capabilities, allowing clinicians to identify abnormal heart rhythms (arrhythmias) by mapping electrical activity in the heart. This enables targeted ablation treatments to disrupt problematic pathways, restoring normal heart function.
Is the EpiFaith CV intended for single-use or reusable applications, and what are the implications for maintenance?
The EpiFaith CV is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical settings like electrophysiology labs. Since it is reusable, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality between procedures. The device is not classified as MRI-safe, so additional precautions must be taken during storage and handling.
How is the regulatory approval process for the EpiFaith CV structured, and what does the ‘Substantially Equivalent’ decision mean?
The EpiFaith CV received FDA clearance through the 510(k) Traditional pathway, meaning its design was compared to a legally marketed predicate device to demonstrate substantial equivalence. The ‘Substantially Equivalent’ (SESE) decision indicates that the device has the same intended use and technological characteristics as the predicate, with no significant differences in risk. It is also authorized under the MDR (Medical Device Regulation) framework, ensuring compliance with both U.S. and EU regulatory standards.
What types of healthcare facilities would benefit most from integrating the EpiFaith CV into their electrophysiology workflow?
The EpiFaith CV is specifically designed for specialized clinical settings such as electrophysiology labs and cardiac catheterization suites, where precise arrhythmia mapping and ablation procedures are performed. These environments require advanced diagnostic tools to assess and treat complex heart rhythm disorders, making the device ideal for high-volume cardiac centers, teaching hospitals, or dedicated arrhythmia clinics.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212615 | Class II | Active |
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Manufacturer
- Manufacturer
- Flat Medical Co., Ltd.
Sources (3)
- FDA 510(k) K212615 24 fields · synced Sep 18, 2026
- FDA UDI 0b9e72c2-8c70-4daa-8412-32329ee8a7da 36 fields · synced May 30, 2026
- EUDAMED 9b51c421-5ab7-4735-ad67-8d54122497a4 61 fields · synced Jul 16, 2026