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510(k) Data Aggregation
K Number
K140321Device Name
INITARY BETTER BLADDER-PEDIATRIC
Manufacturer
CIRCULATORY TECHNOLOGY, INC.
Date Cleared
2014-04-17
(58 days)
Product Code
DTN, DAT
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
CIRCULATORY TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Better-Bladder™ is a device that isolates from blood contact when measurements of blood pressure in extracorporeal circuits are made during term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.
Device Description
The Better-Bladder™ (BB) is a length of standard perfusion tubing, a portion of which has been processed to form a sausage shaped balloon with a thin wall that is then sealed within a clear, rigid housing. This device can be used as an inline blood reservoir during extracorporeal circulation. It can also be used to monitor the blood pressure noninvasively: because the pressure of blood flowing inside the tubing is transmitted across the thin wall to the housing chamber, this pressure can be monitored via a pressure monitoring line to a pressure sensor. The BB thereby serves as a pressure transducer protector, isolating the blood from the pressure sensor and allowing noninvasive pressure measurements, which in turn can be used as input signals to control the pump speed.
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K Number
K012942Device Name
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
Manufacturer
CIRCULATORY TECHNOLOGY, INC.
Date Cleared
2001-11-05
(66 days)
Product Code
DTN
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
CIRCULATORY TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V-Bag™ with the Vac-Box™ are designed for use in an extracorporeal circuit to provide a volume reservoir, compliance, and assist in removing air during the vacuum assisted venous drainage operating mode.
Device Description
Not Found
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K Number
K001822Device Name
THE V-BAG
Manufacturer
CIRCULATORY TECHNOLOGY, INC.
Date Cleared
2000-07-07
(21 days)
Product Code
DTN
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
CIRCULATORY TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K981284Device Name
BETTER-BLADDER (BB)
Manufacturer
CIRCULATORY TECHNOLOGY, INC.
Date Cleared
1998-08-12
(126 days)
Product Code
DTN
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
CIRCULATORY TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.
Device Description
The BB consists of a unitary length of tubing, a section of which has been processed to form an enlarged diameter with a thinner wall. The enlarged section is very responsive to pressure differences across its thin wall. Because the entire device is made from a single length of smooth perfusion tubing, there are no connections between the thinker wall tubing portions. This unique design eliminates both physical and material (chemical) discontinuities. The thin walled section in its housing can withstand over 1500 mmHg (three times the maximum pressure expected under worst-case clinical conditions). The BB does not incorporate vent tubes for air aspiration or drug infusion. These can be added by placing a perfusion connector with a dual Luer fitting (e.g. Avecor Model # DL1414) at the inlet to the BB, see Fig. 7b.
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K Number
K964205Device Name
BETTER-TUBING
Manufacturer
CIRCULATORY TECHNOLOGY, INC.
Date Cleared
1998-04-08
(537 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CIRCULATORY TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.
Device Description
The Better-Tubing™ (BT) is a 6 ft. length of ¼' ID tubing for use in an extracorporeal cardiopulmonary bypass circuit. It is biocompatible, has high tensile strength, and has many advantages over standard tubing made from polyvinyl chloride (PVC).
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K Number
K964337Device Name
BETTER-BLADDER (BB)
Manufacturer
CIRCULATORY TECHNOLOGY, INC.
Date Cleared
1997-05-23
(204 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
CIRCULATORY TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.
Device Description
The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.
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K Number
K961594Device Name
BETTER-VENTER
Manufacturer
CIRCULATORY TECHNOLOGY, INC.
Date Cleared
1996-09-05
(134 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CIRCULATORY TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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