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510(k) Data Aggregation
K Number
K082815Device Name
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
Manufacturer
WELL LEAD MEDICAL INSTRUMENTS
Date Cleared
2008-10-08
(13 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
WELL LEAD MEDICAL INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Two-Way Catheter - Urethral catheterization for bladder drainage for Urological use only
Three Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only
Device Description
The Well Lead Latex and Silicone Foley catheters are two-way Foley catheters which are placed in the bladder throught the urethra. The urine drains out through the catheter into a collection device attached to the catheter.
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K Number
K073383Device Name
WELL LEAD REINFORCED ENDOTRACHEAL TUBE
Manufacturer
WELL LEAD MEDICAL INSTRUMENTS
Date Cleared
2008-07-10
(220 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
WELL LEAD MEDICAL INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Well Lead Reinforced Endotracheal Tubes are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone positiom so that a non-reinforced tracheal tube might become kinked.
Device Description
Single Use. A Tracheal tube with addidional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, and oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen. The Well Lead Reinforced Endotracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric patients or when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.
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K Number
K042683Device Name
WELL LEAD ENDOTRACHEAL TUBE
Manufacturer
WELL LEAD MEDICAL INSTRUMENTS
Date Cleared
2005-02-18
(142 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
WELL LEAD MEDICAL INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for oral or nasal intubation and for airway management.
Device Description
The tracheal tubes are made from medical grade PVC, with a connector and valve. The tracheal tubes may be cuffed or uncuffed and are for oral or nasal use.
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K Number
K042684Device Name
WELL LEAD TRACHEOSTOMY TUBE
Manufacturer
WELL LEAD MEDICAL INSTRUMENTS
Date Cleared
2005-02-17
(141 days)
Product Code
BTO
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
WELL LEAD MEDICAL INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.
Device Description
The tracheostomy tubes are made from the raw material of PVC for medical use, with the The trachetoney wave. The tracheostomy tubes have such good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility.
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