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510(k) Data Aggregation
K Number
K242953Device Name
KIDS Arterial Filters
Manufacturer
Sorin Group Italia S.r.l.
Date Cleared
2024-12-20
(86 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.
The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less.
Device Description
KIDS Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bypass.
These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and they can be used up to 6 hours.
The KIDS Arterial Filters are the modified version of the disposables currently marketed in the D130 PH.I.S.I.O. Dideco Kids Neonatal Arterial Filter (K063255) and the D131 PH.I.S.I.O. Dideco Kids Infant Arterial Filter (K072308).
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K Number
K242092Device Name
MICRO Arterial Filters
Manufacturer
Sorin Group Italia S.r.l.
Date Cleared
2024-11-18
(124 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.
The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised.
Device Description
MICRO Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bvpass.
These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and thev can be used up to 6 hours.
The MICRO Arterial Filters are the modified version of the following currently marketed devices:
a) the D734 Micro 40 included in the Dideco Micro 20 & 40 Adult Arterial Filter (K952270) and in the Dideco MICRO 40 Ph.I.S.I.O. Adult Arterial Filter (K040184); b) the D736 Micro 40 included into the Dideco Newborn/Infant Arterial Filters, 20/40 Micron (K961869) and in the D735 MICRO 20, Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen and for D736 MICRO 40, DIdeco D736 Micro 40 Newborn-Infant Arterial Filter with 40 micron screen (K033987);
c) the D733 Micro 40 included in the D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters (K041061) and in the D731 MICRO 27 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Arterial Filters (K112525).
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K Number
K231362Device Name
OCS Heart Leukocyte Depleting Filter
Manufacturer
TransMedics, Inc.
Date Cleared
2023-10-31
(173 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OCS™ Heart Leukocyte Depleting Filter is indicated for the reduction of leukocytes from donor blood prior to its introduction into the OCS™ Heart System for the preservation of a donor heart from the same donor.
Device Description
The OCS™ Heart Leukocyte Depleting Filter is a sterile, single-use filter intended for depletion of leukocytes in donor blood prior to its introduction into the OCS Heart system. The polycarbonate housing is 3.2" high and 3.0" in diameter. It has 1/4" fittings and includes a hydrophobic gas-permeable membrane and vent port to allow air to efficiently vent during priming and use. The leukocyte depleting material is a melt blown polyester media supplied by Pall Biomedical (the same material as is used in the predicate device). It has 6 layers, approximately 5 pleats per inch. It includes a polypropylene extruded diamond mesh that provides support for the polyester filter media. The priming volume is 273.5 mL and the anticipated flow rate (associated with gravity feed from a blood collection bag) is 1.9 L/min. During use, the blood enters through the inlet port, flows through the filter media to the interior of the filter element, and then exits through the outlet port. The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.
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K Number
K123351Device Name
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
Manufacturer
MEDTRONIC PERFUSION SYSTEMS
Date Cleared
2013-03-19
(139 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
Device Description
The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. The AF100 with Carmeda BioActive Surface (CB851) is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.
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K Number
K122760Device Name
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
Manufacturer
MEDTRONIC INC.
Date Cleared
2012-12-07
(88 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
Device Description
The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
The AF100 with Balance Biosurface (BB851) is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.
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K Number
K121209Device Name
TERUMO PALL AL20X ARTERIAL FILTER
Manufacturer
Terumo Cardiovascular Systems Corporation
Date Cleared
2012-05-08
(18 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Terumo® Pall AL20X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 20 microns in size, including gas emboli, fat emboli, and aggregates composed of platelets, red blood cells, and other debris from the arterial line and where the flow rate will not exceed 7 liters per minute. The device may be used in procedures lasting up to 6 hours in duration.
Device Description
The Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6 Arterial Filter, use the same principles of operation and technology. They perform their functions using two basic forms of technology. As filtration devices, particulates in the blood stream are captured and removed from the blood flow as blood passes through a porous filter material that is contained within the device housing. The filter establishes a physical barrier that entraps particulate matter and prevents it from moving downstream of the arterial filter assembly. As air-removal devices, the Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6X Arterial Filter, are designed so that air is removed from the blood stream as a result of centripetal force. The blood inlet port of the device is positioned on the upper-side axis of the polycarbonate housing, thereby creating a spiral blood flow pattern as blood enters the device. As the blood flows through the device in a spiral motion, centripetal forces cause the air bubbles to migrate towards the top of the housing assembly - where air can subsequently be purged from the circuit.
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K Number
K112525Device Name
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
Manufacturer
PAREXELINTERNATIONAL
Date Cleared
2011-09-29
(29 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D731 MICRO Ph.I.S.I.O. with 27 micron screen with phosphoryIcholine coating and the D733 MICRO Ph.I.S.I.O. with 40 micron screen with phosphoryIcholine coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Device Description
The D731/D733 MICRO Ph.I.S.I.O. Arterial Filters are sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with flow rate not exceeding 6.0 liters/minute. The D731/D733 MICRO Ph.I.S.I.O. are Arterial Filters with 27 and 40 micron filters screen, respectively. The devices are designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris, greater than the pore size, from the arterial line perfusate.
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K Number
K100646Device Name
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
Manufacturer
MEDTRONIC INC.
Date Cleared
2010-12-16
(286 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K093986Device Name
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
Manufacturer
SORIN GROUP ITALIA S.R.L.
Date Cleared
2010-01-22
(29 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AF 620 Ph.I.S.I.O. with 20 micron screen with phosphoryIcholine coating and the AF 640 Ph.I.S.I.O. with 40 micron screen with phosphory choline coating are recommended for use in the arterial line of the extracorporeal nicuti during any procedure that requires cardiopulmonary bypass. The filters, are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Device Description
The AF 620 Ph.1.S.I.O. and 640 Ph.I.S.I.O are sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with flow rate not exceeding 6.0 liters/minute. The AF 620 Ph.I.S.I.O. and 640 Ph.I.S.I.O are Arterial Filters with 20 and 40 micron filters screen, respectively, designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris, greater than the pore size, from the arterial line perfusate. The AF 620 Ph.I.S.I.O. and 640 Ph.I.S.I.O are a modified version of the currently marketed D731 and D733 MICRO Ph.I.S.I.O. The modifications consist of: a different port orientation of the blood outlet port in order to improve the ease of use, ergonomics and fluid dynamics properties; change from polyurethane potting to ultrasonic welding for improved overall biocompatibility; the size of the filter housing has been reduced thus the filter net is double pleated rather than single pleated: the pore size of the filter screen for the AF 620 Ph.I.S.I.O. has been reduced from 27 micron to 20 micron with respect to the D731 MICRO Ph.I.S.I.O. for improved filtration efficiency; a and different formulation of phosphorylcholine monomer has been used to improve wettability. As a consequence of these modifications, the labeling has been updated.
The modified device has unchanged intended use, operating principles, manufacturing, control mechanisms, sterilization process and fundamental scientific technology.
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K Number
K090518Device Name
QUART ARTERIAL FILTER WITH SOFTLINE COATING
Manufacturer
MAQUET CARDIOPULMONARY AG
Date Cleared
2009-12-18
(295 days)
Product Code
DTM
Regulation Number
870.4260Why did this record match?
Product Code :
DTM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QUART Arterial Filter with SOFTLINE COATING is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The max. flow rate of the QUART Arterial Filter is 71/min.
The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.
The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.
Device Description
The QUART Arterial Filter serves as a filter during extracorporeal circulation procedures to safely remove gaseous embolisms and aggregates from blood components in the arterial blood line.
Utilization of the QUART Arterial Filter therefore reduces the patient risk of injury from a micro-embolism resulting from gases or solids.
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