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510(k) Data Aggregation
K Number
K081049Device Name
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
Manufacturer
CRYOCATH TECHNOLOGIES, INC.
Date Cleared
2008-06-27
(74 days)
Product Code
DRA
Regulation Number
870.1280Why did this record match?
Applicant Name (Manufacturer) :
CRYOCATH TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlexCath® Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.
Device Description
The FlexCath® Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein.
It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.
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K Number
K070357Device Name
FLEXCATH STEERABLE SHEATH & DILATOR
Manufacturer
CRYOCATH TECHNOLOGIES, INC.
Date Cleared
2007-12-28
(324 days)
Product Code
DRA
Regulation Number
870.1280Why did this record match?
Applicant Name (Manufacturer) :
CRYOCATH TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
Device Description
The FlexCath™ Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.
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K Number
K062140Device Name
SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1
Manufacturer
CRYOCATH TECHNOLOGIES, INC.
Date Cleared
2006-08-24
(28 days)
Product Code
OCL
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CRYOCATH TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
Device Description
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® XL Cryosurgical Device (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® XL Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost Cryosurgical Probe.
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K Number
K053436Device Name
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
Manufacturer
CRYOCATH TECHNOLOGIES, INC.
Date Cleared
2006-01-13
(35 days)
Product Code
OCL
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CRYOCATH TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte" Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 6cm, 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.
Device Description
The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® Cryosurgical Device (Single Use), FrostByte™ Clamp (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 7cm and 10cm Cryosurgical Probes to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.
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K Number
K040690Device Name
SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
Manufacturer
CRYOCATH TECHNOLOGIES, INC.
Date Cleared
2004-04-29
(44 days)
Product Code
OCL
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CRYOCATH TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.
Device Description
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® Cryosurgical Device (Single Use), FrostByte™ Clamp (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 10 cm Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.
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K Number
K030303Device Name
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
Manufacturer
CRYOCATH TECHNOLOGIES, INC.
Date Cleared
2003-04-29
(90 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CRYOCATH TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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