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510(k) Data Aggregation
K Number
K103469Device Name
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
Manufacturer
SORIN GROUP DEUTSCHLAND GMBH
Date Cleared
2011-01-18
(55 days)
Product Code
KRL
Regulation Number
870.4205Why did this record match?
Product Code :
KRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stöckert Air Purge Control (APC) System detects air in the venous line and removes air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit. The Synergy™/ECC.O™ shall only be used in conjunction with the Stöckert S5 (or any compatible system using the S5 firmware versions of 3.0 or greater) and the SCP Plus System.
The Stöckert S5 System is indicated for speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction and administration of cardioplegia solution.
Device Description
The Stöckert APC System consists of the APC sensor module (Catalog Number: 23-45-22), 3-joint mast holder with fast clamp connectors for two bubble sensors, 420mm (Catalog Number: 23-26-96), bubble sensor for 3/8 inch tubing (Catalog Number: 23-07-50), and ultrasonic gel, bottle, 250 mL (Catalog Number: 96-06-10). All of these components are identical to those used with the Stöckert S5 System (K091008).
The Stöckert APC can be operated automatically and manually using the APC displet of the heart lung machine.
The Stöckert APC bubble trap is placed just before the venous bubble trap of the Synergy™/ECC.OTM. When bubble activity is sensed, the assigned roller pump on the heart lung machine console begins operation to remove a set tubing volume (as determined by tubing size and pump speed (RPM)) or to run for a set time (in seconds) at a perfusionist-selected flow rate. This fluid is pumped into an appropriate blood collection reservoir. The technology of the Stöckert APC is based on the technology of the Stöckert Air Purge Control System (K041558).
The Stöckert APC is used for detecting air in the venous line and removing air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit.
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K Number
K090698Device Name
CAPIOX BUBBLE TRAP WITH X-COATING
Manufacturer
TERUMO CARDIOVASCULAR SYSTEMS
Date Cleared
2009-06-08
(83 days)
Product Code
KRL
Regulation Number
870.4205Why did this record match?
Product Code :
KRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Capiox® Bubble Trap with X-coating " is a device intended to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.
Device Description
The Capiox® Bubble Trap with X-coating is comprised of a single outer housing with no inner housing. This outer housing is cylindrical in shape and has a slight conical-shaped lid assembly affixed to the upper area of the cylinder. The lid assembly has an air vent (purge) port on the top outer surface to facilitate air removal during use. The blood inlet port is positioned along the upper-side_axis_of_the_cylinder_housing_and_allows_for the entry of blood ... The base_of_the housing contains the blood outlet port. The cylinder housing contains a screen filter assembly through which blood will pass through for filtration of air bubbles. After the blood has been filtered, it then exits the assembly via the blood outlet port.
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K Number
K071231Device Name
EDAC QUANTIFIER
Manufacturer
LUNA INNOVATIONS, INC.
Date Cleared
2007-05-17
(14 days)
Product Code
KRL
Regulation Number
870.4205Why did this record match?
Product Code :
KRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EDAC™ QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.
Device Description
The EDAC™ QUANTIFIER is a standalone system in which the ultrasonic sensing system consists of a three-channel ultrasonic pulser-receiver unit, a touchpanel computer, ultrasound transducers and clamps for attached the transducers to the circuit. This system is currently being certified according to voluntary medical device safety standards UL 60601-1 . IEC 60601-1-2 and IEC 60601-1-4, covering electrical device safety in medical products and IEC-60601-2-37, covering ultrasonic diagnostic safety. It also employs software and firmware to provide the embedded signal processing needed to detect gas emboli over the range of sizes described.
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K Number
K961364Device Name
AUTOMATIC TUBING CLAMP SYSTEM (ATC)
Manufacturer
ROCKY MOUNTAIN RESEARCH, INC.
Date Cleared
1996-10-31
(205 days)
Product Code
KRL
Regulation Number
870.4205Why did this record match?
Product Code :
KRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961598Device Name
ELS AUTOMATIC TUBING CLAMP SYSTEM
Manufacturer
ROCKY MOUNTAIN RESEARCH, INC.
Date Cleared
1996-10-29
(203 days)
Product Code
KRL
Regulation Number
870.4205Why did this record match?
Product Code :
KRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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