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Found 28 results
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?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250545Device Name
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2025-06-05
(100 days)
Product Code
OWQ
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F 10FG are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO 3 EP Navigation Systems, the SOUNDSTAR eco Catheter provides location information.
Device Description
The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F, 10FG are licensed for single use only. Models differ in shaft diameter (8F or 10F) and ultrasound system compatibility (Siemens [8F and 10F] or GE [8FG and 10FG]). The catheter consists of a CARTO connector, SwiftLink (ultrasound) connector, handle and shaft. In the distal tip of each catheter's shaft are a 64-element ultrasound transducer providing 2D imaging and a 3D location sensor providing location information to the compatible CARTO 3 Electrophysiology (EP) Navigation System. The deflection and tension knobs on the handle are used to articulate the distal tip and control the image plane orientation with four-directional (anterior-posterior, left-right) deflection.
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K Number
K243101Device Name
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2025-03-10
(161 days)
Product Code
OWQ
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only not treatment delivery, during cardiac interventional percutaneous procedures.
Device Description
The Medline ReNewal Reprocessed Siemens AcuNav Diagnostic Ultrasound Catheters 10F are licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheters are to be used only on systems with which they have been tested and found compatible.
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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?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
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?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
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
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?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
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
K234064Device Name
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2024-09-10
(263 days)
Product Code
OWQ
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheter is inteacardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Device Description
The Medline ReNewal Reprocessed AcuNav Diagnostic Ultrasound Catheters 8F are licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheters are to be used only on systems with which they have been tested and found compatible.
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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?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
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
K232511Device Name
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2024-04-29
(255 days)
Product Code
NUJ, GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels. Ivmphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
Device Description
The Medline ReNewal Remanufactured LigaSure Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, handle-held bipolar vessel sealing device designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. A hemostat style body allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the device.
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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?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings Inc
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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