EpiFaith CV
EpiFaith CV assists guidewire placement during central venous catheterization. It connects to an appropriate introducer needle and provides a visible pressure cue when the needle enters a…
EpiFaith CV assists guidewire placement during central venous catheterization. It connects to an appropriate introducer needle and provides a visible pressure cue when the needle enters a vessel with pressure greater than 50 mmHg. Neonates and infants are excluded from its intended population.
The syringe contains a spring loaded piston. Blood pressure entering the barrel pushes the piston backward, producing a visual indication of the pressure at the needle tip while supporting guidewire assisted placement.
Listed Item
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.
Connections and Supply
The device accepts guidewires from 0.025 to 0.038 inch with suitable introducer needles and uses a Luer connection. It is supplied sterile after ethylene oxide processing, individually packaged or as part of a sterile kit, for single use.
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Flat Medical Co., Ltd., Taiwan |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K212615 |
| Record published | 2022-10-26 |
| Record revised | 2023-02-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 25, box of 300 |
| Sizes | Length 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FM-11SLR | Length 80 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
Showing 12 of 525. All products under Wire, Guide, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212615 | 2022-09-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.