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510(k) Data Aggregation
K Number
K072697Device Name
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
Manufacturer
Date Cleared
2007-12-20
(87 days)
Product Code
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
3T MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K022287Device Name
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
Manufacturer
Date Cleared
2002-09-23
(70 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
3T MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three-Way catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization. Temperature Sensing Catheter: Urethral catheterization for bladder drainage and or irrigation with simultaneous temperature monitoring.
Device Description
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K Number
K020768Device Name
3T VESSEL CANNULAS
Manufacturer
Date Cleared
2002-08-23
(169 days)
Product Code
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
3T MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
3T Medical Systems vessel cannulas are indicated for use during open-heart surgery or in vascular surgery to help check for leaks in a harvested vein which will be used for a graft.
Device Description
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K Number
K020365Device Name
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
Manufacturer
Date Cleared
2002-05-03
(88 days)
Product Code
Regulation Number
870.4200Why did this record match?
Applicant Name (Manufacturer) :
3T MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium.
Device Description
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K Number
K001245Device Name
3T L. V. CONTROL VALVE
Manufacturer
Date Cleared
2001-08-15
(484 days)
Product Code
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
3T MEDICAL SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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