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510(k) Data Aggregation
K Number
K153599Device Name
Concert Medical Hands-Free Syringe (HFS)
Manufacturer
Date Cleared
2016-09-01
(260 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Concert Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Concert Medical Hands-Free Syringe (HFS) is indicated for general fluid irrigation/infiltration.
Device Description
The Concert Medical Hands-Free Syringe (HFS) is an infiltration pump used to infuse fluids (such as regional anesthetics) into the body. The HFS consists of a sterile, single-use plastic syringe (20 mL capacity) fitted with a custom plunger, a reusable motor housing, and a reusable foot pedal. The user fills the syringe with the fluid of choice, then locks the filled syringe into the motor housing, where the specially designed syringe plunger rack mates with the custom plunger housing gear. The male luer fitting of a sterile, single-use needle set (not supplied by Concert Medical) is attached to the standard female luer fitting on the HFS syringe. The foot pedal connector is plugged into the receptacle on the motor housing, then the foot pedal is placed in a convenient location on the floor. The motor housing contains non-replaceable AAA batteries, which power a small DC motor which in turn controls the movement of the syringe plunger. The foot pedal consists of a color-coded rubber bar; when the user applies light foot pressure to the appropriate half of the foot pedal (green = infuse; yellow = aspirate), the motor activates the plunger movement mechanism to move the plunger forward (infuse) or backward (aspirate). The motor control is designed to deliver fluid at a maximum flow rate of 0.5 mL/sec. The motor is designed with an overpressure safety feature, which causes the plunger movement to stop if the pressure in the syringe exceeds 15 psi regardless of whether the "infuse" portion of the foot pedal is depressed. The motor housing has three LED indicator lights for real-time display of the syringe plunger action: a green light illuminates when the syringe is infusing, a yellow light illuminates when the syringe is aspirating, and a red light illuminates if the plunger movement has stopped because the 15 psi pressure limit has been reached. The foot pedal control provides the user with two-handed control of the needle placement without the need for a second person to manipulate the syringe plunger for infusion or aspiration.
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K Number
K153397Device Name
S-Wire Guidewire System
Manufacturer
Date Cleared
2016-08-18
(268 days)
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
CONCERT MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The S-Wire Guidewire System is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used in trans-catheter aortic valve implantation (TAVI) procedures.
Device Description
The S-Wire Guidewire System is a sterile, single-use guidewire used for the placement of interventional devices within the aorta and the chambers of the heart. The S-Wire has a 0.035" diameter, and an overall length of 260 cm. The S-Wire construction consists of a nickel-titanium alloy core wire that is PTFE coated, ground and thermally formed. The S-Wire distal coil is made of 304V stainless steel: the distal and proximal ends of the stainless steel coil is bonded to the core wire. The distal portion of the S-Wire has silicone coating. The distal end of the S-Wire has a pre-formed double curve shape consisting of an approximately 360° bend with an outer diameter of approximately 3 cm, and a small S-curve at the distal tip of the wire that is fully contained within the 3 cm curved area. The S-Wire Guidewire System includes a disposable plastic 9 Fr introducer (6 inches long) that is used as an aid in loading the S-Wire into an intravascular catheter.
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K Number
K090193Device Name
CONDUCTOR CORONARY GUIDEWIRE
Manufacturer
Date Cleared
2009-09-25
(241 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
CONCERT MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.
Device Description
The Concert Medical Conductor coronary guidewire consists of a flexible wire that is available with silicone or hydrophilic coating. The wire is intended to guide the placement of intravasculable will with compatible lumens during PTCA or other therapeutic or diagnostic procedures.
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