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510(k) Data Aggregation
K Number
K250772Device Name
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2025-07-11
(120 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K242225Device Name
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2024-11-29
(123 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters can be used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.
Device Description
The Medline ReNewal Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle of the proximal end of the catheter.
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K Number
K241224Device Name
Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
Manufacturer
Surgical Instrument Service and Savings Inc.(dba Medline ReN
Date Cleared
2024-11-15
(197 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Biosense Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
Device Description
The reprocessed catheters are diagnostic bi-directional 7F deflectable mapping electrophysiology EP catheters. The devices have the ability to map electrical activity within the Coronary Sinus (CS) through electrodes along the catheters' pre-shaped tip. The catheters have a braided bi-directional tip section that provides the user with two 180° opposed single plane curves (available curves are DF and FJ). The tip is deflected with a Rocker Lever, and the high torque shaft permits the tip's plane to rotate to ease accurate positioning of the catheter tip at the desired site. The Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID are equipped with an Electronically Erasable Programmable Read Only Memory (EEPROM) that is used to store unique catheter identification information.
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K Number
K240826Device Name
Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
Manufacturer
Sterilmed, Inc.
Date Cleared
2024-10-11
(199 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed DECANAV™ Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, in the Coronary Sinus. In addition, the Reprocessed DECANAV™ Catheter is used with compatible Carto® 3 EP Navigation Systems to provide catheter tip location information.
The Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. In addition, the Reprocessed WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and coronary sinus.
Device Description
The Reprocessed DECANAV™ Catheter is a sterile, single patient use device designed to be used with the CARTO® 3 EP Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The Reprocessed DECANAV™ Catheter has a single proximal electrode that can be used for unipolar recording signals. The Reprocessed DECANAV™ Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in curve types D and F. Pushing the thumb knob forward causes the catheter tip to bend (curve); when the knob is pulled back, the tip straightens. The plane of the curved tip can be rotated during use. The Reprocessed DECANAV™ Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.
The Reprocessed WEBSTER® Duo-Decapolar Catheter (DDP) is a sterile, single patient use device designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. Tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumb knob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.
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K Number
K241156Device Name
Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2024-09-14
(141 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheters and Supreme Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmia from endocardial and intravascular sites.
Device Description
Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are fixed electrode catheters constructed of a polyurethane insulation/shaft and incorporate platinum electrodes. Each device is marked and tracked and will be taken out of service once the maximum number of cycles has been reached.
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K Number
K233825Device Name
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
Manufacturer
Innovative Health
Date Cleared
2024-06-07
(189 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial reqion of the heart and the coronary sinus.
Device Description
The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.
The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
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K Number
K240972Device Name
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2024-06-07
(59 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The cable is designed for use only with the Medronic Achieve family of mapping catheters. It is intended to provide the connection of the catheter to a standard ECG interface box.
Device Description
The Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable is licensed for single use only. It connects the catheter and console to provide a path of electrical transmission from the proximal end of an Achieve mapping catheter to standard shielded ECG pins that connect to standard EP pacing and recording equipment. The cable is designed to only be used with the Medtronic Achieve family of mapping catheters
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K Number
K221067Device Name
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2023-05-31
(414 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Device Description
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at the proximal end of the catheter.
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K Number
K221854Device Name
Reprocesses Umbilical Cable
Manufacturer
Innovative Health, LLC.
Date Cleared
2022-08-06
(40 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.
Device Description
The reprocessed umbilical cable is an insulated, multi-conductor cable that us 200 cm (6.6 ft) in length with multi-pin connectors at each end.
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K Number
K211276Device Name
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
Manufacturer
Innovative Health, LLC.
Date Cleared
2021-09-15
(141 days)
Product Code
NLH, REP
Regulation Number
870.1220Why did this record match?
Product Code :
NLH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Device Description
The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic Electrophysiology (EP) Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
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