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510(k) Data Aggregation
K Number
K053051Device Name
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-12-22
(55 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
Device Description
Vanguard Reprocessed External Fixation Devices are previously used noninvasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External Fixation Device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight rods, telescoping rods, rod-to-rod and pin-to-rod couplings and clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.
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K Number
K051616Device Name
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-09-06
(81 days)
Product Code
KTT, LXT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
Device Description
Vanguard Reprocessed External Fixation Devices are previously used non-Device invasive orthopedic devices that have been cleaned, inspected, tested, and Description packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation.
External fixation elements consist of components such as rails and modular rails, rail-to-rail couplings, rail-to-screw clamps, rail-to-clamp couplings, rail-to-clamp couplings, and clamp-to-clamp couplings. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.
Rods. Rails and Modular Rails ~ Straight rods and rails are external fixation devices of varying lengths (adjustable in the case of modular rods and rails) and dimensions that are used with rail-to-rail, rod-to-rail, rod/rail-to-ring, and rail-to-screw clamps by the surgeon to connect anchoring pins and screws together to form a rigid structure that immobilizes the affected bone or Differences in the dimensions of the rods and rails allow structures. accommodation of a broad range of fracture scenarios and applied loads. All rods and rails have a straight, solid design. These devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.
Rings and Ring Segments ~ Rings and ring segments are circular or semicircular segments manufactured to surround the area of attachment to bone located centrally in the ring. Various attachments are made to the rings or ring segments to stabilize bone fractures or to reduce or extend the length of Tensioned wires or pins are commonly attached to rings and ring bones. segments using clamps designed for this purpose. Multiple ring or ring segment constructs are used to stabilize and structurally support the anatomical structures being treated using a range of configurations and attachments and connectors. The rings and ring segments are manufactured in a range of diameters to allow selection of a size most appropriate to the anatomy and application needed. Rings and ring segments are typically manufactured from one or more of the following materials: anodized aluminum alloys, steel and stainless steel alloys or carbon fiber composites.
Ring-to-Rod/Rail Clamps ~ Ring-to-rod/rail clamps are utilized to connect a Ring-to-KourKail Claimps - Iting to today in these attachments are made to form an ring of Ting segment to a routine as required for the particular biomechanical external fixator frame construct us requence to requence typically constructed from needs of the procedure. Italy to rearmials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.
Ring-to-Pin or Ring-to-Wire Clamps ~ Ring-to-pin or ring-to-wire clamps u Ring-to-Fin of Ring-to-Wire Or ring or ring or ring segment to a pin or wire that is normally attached on one side of the ring, passed through the bone, wire that is normally attachment point on the opposite side of the ring where and continue to an attacimient point on another ring to wire clamp. Ring-to-pin or wire clamps are used to secure the ring to a pin, wire or set of pins and wires wire clamps are used to seears assing centrally through the external fixation that are anchored in the octor pare clamps are typically constructed from one Inig. King-to-pin and ring to wire claims alloys, steel and/or stainless steel alloys and titanium alloys.
Rod/Rail-to-Screw Clamps ~ Rod/Rail-to-screw clamps are utilized to 8 Rour Ran-to-Screw - Califfer - Califfer - Station raily affixed to the bone. connect an excential rination fail to a proscrews that are anchored in the bone.
DFS System rod/rail-to-screw clamps are V-shaped to provide tri-planar DPS System Todaran to seren. Distraction components are affixed to certain compression of DFS Distal Radius Fixator rod/rail-to-screw clamps to provide Houcis of Dro Distal Rather distal fixator rail. The devices are typically clistiacted from one of the following materials: anodized aluminum and stainless steel.
Rail-to-Rail Couplings ~ Rail-to-Rail couplings are multi-element . Components used to connect one rail to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a by the individual blanks of rails. These devices are typically constructed specific size of railge of the following materials: anodized aluminum and stainless steel.
Rod-to-Rail Couplings ~ Rod-to-Rail couplings are multi-element . Kou-to-Kan - Couplines
components used to connect one rod to a rail in a range of positions defined by the individual clamp configuration. They are designed to interconnect a the individual olanip connigation of rods and rails. These devices are typically specific size or a rangor more of the following materials: anodized aluminum and stainless steel.
Rod-to-Rod Couplings ~ Rod-to-Rod couplings are multi-element 제 Device components used to connect one rod to another in a range of positions Description defined by the individual clamp configuration. They are designed to (continued) denned by and meetific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rail-to-Clamp Couplings ~ Rail-to-clamp couplings are multi-element 트 components used to connect one rail to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rails. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rod-to-Clamp Couplings ~ Rod-to-clamp couplings are multi-clement 8 components used to connect one rod to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Clamp-to-Clamp Couplings ~ Clamp-to-clamp couplings are multi-element 해 components used to connect one clamp to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of clamps. The devices are typically constructed from one or more of the following materials: anodized aluminum or stainless steel.
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K Number
K051180Device Name
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-07-22
(74 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
Device Description
Vanguard Reprocessed External Fixation Devices are previously used non-invasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight and curved rods, rod-to-rod, and rod-to-pin couplings and clamps, rings and ring segments, ring-to-rod, and ring-to-pin clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.
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K Number
K051043Device Name
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-06-06
(42 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g., evaluation of arrhythmias or cardiac mapping.
Device Description
Vanguard reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 6 French in diameter and 110 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector at the end of the hand piece for bi-directional transmission of electrical signals (pacing and recording). The proximal connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment. The distal tip segment of the catheter is capable of unidirectional steering through manipulation of the hand piece. This remote manipulation of the distal tip segment facilitates precise positioning of the electrode array. The catheters are available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream.
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K Number
K050763Device Name
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-06-01
(69 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Device Description
Vanguard reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 6 - 8 French in diameter and 110 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector at the end of the hand piece for bi-directional transmission of electrical signals (pacing and recording). The proximal connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment. The catheters are available with various steerable distal curves for remote manipulation of the distal tip segment to facilitate precise positioning of the electrode array. The catheters are also available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream. In clinical use, diagnostic electrophysiology catheters are placed under fluoroscopy within the heart, near major structures of the conduction system. The effects of pacing on the conduction system and time intervals between waveforms are recorded, measured, and compared to baseline and normal values. The electrocardiogram normally has atrial, His, and ventricular components in order to obtain accurate interval measurements which are used to establish the baseline and current status of the conduction system.
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K Number
K043198Device Name
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-05-27
(190 days)
Product Code
NUJ
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow, and wrist) that utilize a conductive irrigant.
Device Description
Not Found
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K Number
K043253Device Name
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-04-08
(135 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
Device Description
Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.
Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 5-15cm length. Cannulae are equipped with a pressure seal for maintenance of pneumopertineum during insertion and withdrawal of instruments. Some models are equipped with a luer stopcock port for insufflation and desufflation of the operative cavity. Some models are provided with stability anchors inserted over the cannula sleeve to help seal the incision site and maintain cavity pressure.
Trocar Obturator is available in shielded and non-shielded configurations sized 5-15mm. Models equipped with a safety shield are designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated, so as to reduce the risk for vascular or visceral injury. Non-shielded optical obturators are equipped with a clear tip and an 11-12mm video laparoscopy channel to allow trocar insertion under direct visual guidance and minimize the risk for internal injury.
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K Number
K043594Device Name
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-03-31
(92 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
Device Description
A Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.
Trocar Cannulae are available in sizes 5-15mm inner diameter and 70-100mm length. Cannulae are equipped with a pressure seal for maintenance of pneumopertineum during insertion and withdrawal of instruments. Some models are equipped with a luer stopcock port for insufflation and desufflation of the operative cavity. Some models are provided with stability anchors inserted over the cannula sleeve to help seal the incision site and maintain cavity pressure.
Trocar Obturator is available in bladed and non-bladed configurations sized 5-15mm. Bladed models are equipped with a safety shield designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated so as to reduce the risk for vascular or visceral injury.
Non-Bladed obturators have either a rounded (blunt) tip or sharply tapered (dilator) tip to allow trocar insertion following a cut down and minimize the risk for internal injury.
Vanguard receives previously used trocars from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
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K Number
K043225Device Name
VANGUARD REPROCESSED ULTRASONIC SCALPEL
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-03-22
(120 days)
Product Code
NLQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.
Device Description
The Reprocessed Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with functional lengths of 14 to 36cm. The instrument jaws are opened and closed using proximal ring handles, available with a pistol or scissor grip style. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. Scalpels are available with various blade configurations: curved, blunt, and knife down.
The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade.
Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
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K Number
K043315Device Name
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-03-22
(111 days)
Product Code
NLQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
VANGUARD MEDICAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Hand-Activated Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.
Device Description
The Reprocessed Hand-Activated Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with a functional length of 36cm. The instrument jaws are opened and closed using proximal ring handles, styled in a pistol-type grip. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. The Scalpel has a curved active blade. The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade. The proximal handle of the Hand-Activated Ultrasonic Scalpel has two integrated push buttons that allow hand control of the ultrasonic power level (minimum or maximum power level). Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
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