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Found 8 results
510(k) Data Aggregation
K Number
K000004Device Name
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
Manufacturer
DAIG CORP.
Date Cleared
2000-11-29
(331 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
DAIG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994334Device Name
ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
Manufacturer
DAIG CORP.
Date Cleared
2000-05-15
(144 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
DAIG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
Device Description
The Daig Ultra-Flex Hemostasis Introducer is an Introducer designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site during introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel.
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K Number
K982299Device Name
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
Manufacturer
DAIG CORP.
Date Cleared
1998-10-19
(110 days)
Product Code
DQO, DOO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
DAIG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Daig SpyglassTM angiographic catheters are designed for delivery of radiopaque contrast media during angiographic procedures.
The 5Fr Spyglass™ Angiographic Catheter is designed for delivery of radiopaque contrast media during angiographic procedures.
Device Description
Daig SpyglassTM angiographic catheters are radiopaque polymer reinforced with braided stainless steel. This construction yields a small diameter catheter, which retains strength and high flow rate capabilities. A soft atraumatic tip provides good memory and protects against vessel damage. Preformed tip shapes matching or complementing specific anatomy allow access into a variety of vessels.
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K Number
K982187Device Name
FAST-CATH INTRA-CARDIAC INTRODUCER
Manufacturer
DAIG CORP.
Date Cleared
1998-09-16
(86 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
DAIG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fast-Cath™ Intra-Cardiac Introducer is intended for use when introducing various cardiovascular catheters or biopsy devices into the heart.
Device Description
The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction/exchange. A sideport with a Three-way stopcock is provided for air aspiration, fluid infusion, blood sampling, etc.
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K Number
K973840Device Name
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
Manufacturer
DAIG CORP.
Date Cleared
1998-05-21
(225 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
DAIG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when Introducing various cardiovascular catheters or biopsy devices into the heart.
Device Description
The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction / exchange. A side port with a three way stop cock is provided for air aspiration, fluid infusion, blood sampling, etc.
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K Number
K964518Device Name
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
Manufacturer
DAIG CORP.
Date Cleared
1997-05-14
(201 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
DAIG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K965249Device Name
SPYGLASS ANGIOGRAPHIC CATHETER
Manufacturer
DAIG CORP.
Date Cleared
1997-02-21
(71 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
DAIG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962805Device Name
SPYGLASS ANGIOGRAPHIC CATHETER
Manufacturer
DAIG CORP.
Date Cleared
1996-10-15
(89 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
DAIG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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