Search Results
Found 3 results
510(k) Data Aggregation
K Number
K212615Device Name
EpiFaith CV
Manufacturer
Date Cleared
2022-09-21
(399 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Flat Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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"(0.64mm) to 0.038"(0.96mm) 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.
Device Description
The EpiFaith CV is a syringe with spring loaded piston, which can provide a high/low blood pressure signal when introducer needle tip entry to the blood vessel. Based on the principle of blood pressure differences in different blood vessel, the piston will simultaneously move backward when the pressure increase occurs due to the high blood pressure in the syringe barrel. The moving of the piston can provide a visual signal to indicate the high/low blood pressure as well as verify the introducer needle tip placement in the blood vessel.
Ask a Question
Ask a specific question about this device
K Number
K192421Device Name
EpiFaith Syringe
Manufacturer
Date Cleared
2019-09-27
(23 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Flat Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.
Device Description
The EpiFaith is a loss of resistance syringe with spring loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of LOR technique, the piston will simultaneously move forward when the pressure drop occurs due to the spring force. The moving of the piston can provide a visual signal to indicate the LOR as well as verify the needle tip placement in the epidural space. The EpiFaith syringe is compatible to a 16-18 gauge epidural needle with Luer or NRFit connector. The user can push the plunger to increase the pressure after the syringe is connected to an inserted needle. Then, the user can advance the needle until the visual signal occurring. Because the piston is spring loaded, the automatic ejection of the syringe will happen when the LOR occurring, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed below. The only difference between two models is the type of the connector.
Ask a Question
Ask a specific question about this device
K Number
K182268Device Name
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
Manufacturer
Date Cleared
2019-04-05
(227 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Flat Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.
Device Description
The EpiFaith is a loss of resistance syringe with a spring-loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of the LOR technique, the piston will simultaneously move forward when the pressure drop occurs due to the spring force. The moving of the piston can provide a visual signal to indicate the LOR as well as assist in verifying the needle tip placement in the epidural space. The EpiFaith syringe is compatible to a 16-18 gauge epidural needle with Luer or NRFit connector. The user can push the plunger to increase the pressure after the syringe is connected to an inserted needle. Then, the user can advance the needle until the visual signal occurs. Because the piston is spring loaded, the automatic ejection of the content of the syringe will happen when the LOR occurs, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed in Table 4.1. The only differences between two models are the type of the connector and color.
Ask a Question
Ask a specific question about this device
Page 1 of 1