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510(k) Data Aggregation
K Number
K033991Device Name
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
Manufacturer
PALL MEDICAL
Date Cleared
2004-01-22
(30 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
PALL MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The modified Laparoshield Conditioned Insufflation Set ("Laparoshield") is intended to be used as an accessory to an insufflator to heat, humidify and filter a gas stream used for insufflation during laparoscopic surgery. It is indicated for use with CO2.
Device Description
The modified Laparoshield consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a constant voltage/voltage limited power supply. The patient end of the heater wire is encased in a hydrating wick. Gas flows through the annulus created by the wick and outer tubing. The proximity of the heating wire and hydrated wick produce warms and humidifies CO2 from the insufflator. A temperature strip indicates under, normal, and over temperature conditions. The set has a universal connector for compatibility with insufflation machines with Luer, 15mm/22mm ISO 5356-1 and hose-barb gas ports and a trocar.
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K Number
K030469Device Name
LAPAROSHIELD CONDITIONED INSUFFLATION SET
Manufacturer
PALL MEDICAL
Date Cleared
2003-05-09
(86 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
PALL MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laparoshield Conditioned Insufflation Set is intended for use as an accessory to an insufflator to heat, humidify, and filter a gas stream used for insufflation during laparoscopic surgery. The device is indicated for use with CO2
Device Description
The Laparoshield Conditioned Insufflation Set consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a temperature control unit integrated into the power supply component of the device. The patient end of the heater wire is encased in a hydrating wick. Gas flows through the annulus created by the wick and outer tubing. The proximity of the heating wire and hydrated wick produce warms and humidifies CO2 from the insufflator. A temperature strip indicates under, normal, and over temperature conditions. The set has a universal connector for compatibility with insufflation machines with Luer, 15mm/22mm ISO 5356-1 and hose-barb gas ports and a trocar.
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K Number
K013093Device Name
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
Manufacturer
PALL MEDICAL
Date Cleared
2002-08-01
(318 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
PALL MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pall Ultipor Anesthesia Breathing Circuit System with a Breathing System Filter ("BSF") is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient, by means of an oronasal facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.
Device Description
Both the Ultipor and Zefon consist of a patient kit and a machine kit. The components of the both Ultipor's and Zefon's patient kits are: (1) the BSF; (2) face mask; and (3) mask elbow. The components of both Ultipor's and Zefon's machine kit are: (1) the reservoir bag; (2) expiratory tubing; and (3) inspiratory tubing. Ultipor and Zefon both have a gas monitoring line; this line is a component of Ultipor's machine kit and Zefon's patient kit. Both devices' machine kits connect the inspiratory and expiratory ports of the anesthesia machine to their BSF. The respective components of both devices perform the same function(s).
In addition, all of the components of the Ultipor's and Zefon's patient kits are single use and all of the components of these devices' machine kits are for use up to 24 hours, which may include use on multiple patients ("24 hour/multiple patient use"). when used with their respective patient kits.
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K Number
K992361Device Name
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
Manufacturer
PALL MEDICAL
Date Cleared
1999-08-20
(36 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
PALL MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed device is intended for the filtration of contaminants from smoke, generated during laparoacopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria, and viruses).
Device Description
Pall Laparoscopic Smoke Filtration System
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K Number
K983735Device Name
PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE
Manufacturer
PALL MEDICAL
Date Cleared
1999-01-07
(77 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
PALL MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retrolit existing dental waterlines.
Device Description
Pall Medical's Dental Unit Waterline Filtration system with Air Water Syringe Housing and Filtration Membrane. The system consists of reusable filter housings and disposable filter elements.
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K Number
K983731Device Name
PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE
Manufacturer
PALL MEDICAL
Date Cleared
1998-12-21
(60 days)
Product Code
EIA, DAT
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
PALL MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retro: it existing dental waterlines.
Device Description
Pall Medical's Dental Unit Waterline Filtration System with Inline Handpiece Housing and Filtration Membrane
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