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510(k) Data Aggregation
K Number
K251054Device Name
Hem-o-lok PurplePlus Large Polymer Ligating Clips
Manufacturer
Teleflex Medical
Date Cleared
2025-07-03
(90 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K242495Device Name
LMA Fastrach ETT SU
Manufacturer
Teleflex Medical
Date Cleared
2025-04-29
(250 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™.
The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach ™ ETT Single Use in place.
Device Description
The LMA® Fastrach™ ETT Single Use has been developed specifically for use with the LMA® Fastrach™. It is a straight, cuffed, wire-reinforced tube with a Murphy Eye and a standard 15mm connector.
The LMA® Fastrach™ ETT Single Use has a pilot balloon with a luer check valve and a unique, soft, moulded tip for atraumatic passage through the vocal cords. As a reference during intubation, the LMA® Fastrach™ ETT Single Use has depth markers to indicate the distance to the distal tip of the LMA™ airway. The LMA® Fastrach™ ETT Single Use is radiopaque along its full length and its tip is made out of a radio opaque material to enhance its visibility in x-rays.
Accessory device: The Stabiliser Rod Single Use is an accessory and it is indicated for use during removal of the reusable LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the Endotracheal Tube (ETT) in place.
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K Number
K243553Device Name
QuikClot Control+ Hemostatic Device
Manufacturer
Teleflex Medical
Date Cleared
2025-03-18
(120 days)
Product Code
POD
Regulation Number
878.4454Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.
Device Description
QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal.
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K Number
K241784Device Name
Arrow® Nitinol Wire
Manufacturer
Teleflex Medical
Date Cleared
2024-09-18
(90 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arrow® Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.
Device Description
The Arrow® Nitinol Wires are composed of a coil wire wrapped around a solid core wire, designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel to ensure proper tip placement of the catheter. The clinical benefit of the Arrow® Nitinol Wire is allow the clinician the ability to guide and control the advancing movement of the catheter body through the vessel gaining access to the vascular system through a single puncture site. The guidewires in Arrow / Teleflex Vascular finished goods are typically provided as Spring Wire Guide assemblies including additional components (straightener, Arrow Advancer, tubing clamps, snubber) for easier handling.
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K Number
K232469Device Name
Rüsch Latex Gold Foley Catheter
Manufacturer
Teleflex Medical, Inc.
Date Cleared
2024-08-01
(352 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
2 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required ether postoperatively or for patients with conditions requiring urine drainage.
3 Way Latex Foley Catheter
Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.
Device Description
The Rüsch Latex Gold Foley Catheter is available as 2 Way catheter, with a proximal funnel, non-return inflation valve and bladder fixation balloon, and 3 Way catheter which includes an additional irrigation channel with proximal funnel. The catheter is manufactured of natural latex, provided sterile, single use, and disposable. The inflation valve is designed for use with Luer lock syringe tips. Balloon inflation volumes in millimeters, as well as shaft size in French gauge (Fr.), Charrière (Ch.), or millimeters (mm), are indicated on the funnel of each individual catheters are siliconized, or surface finished with Polytetrafluoroethylene (PTFE). The Gold Foley Catheter maximum use/indwelling period is less than 30 days. The device has different models of catheters namely PURE GOLD, Gold Pediatric, Gold, and the Gold Haematuria.
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K Number
K233713Device Name
Pilling Tracheostomy Tubes
Manufacturer
Teleflex Medical
Date Cleared
2024-03-22
(123 days)
Product Code
BTO
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tracheostomy tubes are intended to provide tracheal access for airway management of tracheostomized patients.
Device Description
Pilling™ Tracheostomy Tubes are stainless-steel tracheostomy tubes that are intended to provide tracheal access for airway management of tracheostomized patients. The tracheostomy tubes are reusable, single-patient devices that are provided non-sterile, and intended to be cleaned prior to initial use. Each tube consists of an outer cannula, inner cannula, and pilot/obturator. The inner and outer tubes fit closely to provide maximum airway. The distal edge of the inner tube is flush with, and fits very closely to, that of the outer tube to allow for complete cleaning. Variations in diameter, shape of the inner and outer tubes (radius of curvature), locking mechanism, and neck plate configurations are the basis of the various styles available.
The tubes are available in sizes ranging from 00 (4.5mm outside diameter, 2.4mm inside diameter) to 12 (16.3mm outside diameter. 12.7mm inside diameter) based on individual style. Insertable lengths range from 33mm (size 00) to 85mm (size 9 Extra Long) based on individual style. Shape of the device and specific design of the neck plate and locking feature is based on style (Jackson, Jackson Improved, and Mayo).
Some Pilling™ Tracheostomy Tubes are fenestrated to facilitate speech and all tubes can be fenestrated upon request. Certain inner tubes are compatible with the Shikani-French Speaking Valve (Product Code JOH, 510(k) K982128). Pilling™ Tracheostomy Tubes are available in models with or without permanently attached 15mm adapters.
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K Number
K232970Device Name
Hem-o-lok® Ligating Clips
Manufacturer
Teleflex Medical
Date Cleared
2024-01-12
(113 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hem-o-lok® Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Device Description
Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.
Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.
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K Number
K230603Device Name
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
Manufacturer
Teleflex Medical
Date Cleared
2023-08-30
(180 days)
Product Code
BSO, CAZ
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions for use.
The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
The Arrow FlexBlock Continuous Peripheral Nerve Block Kit Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Device Description
The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.
Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.
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K Number
K212077Device Name
Teleflex Rusch SoftSimplastic Foley Catheters
Manufacturer
Teleflex Medical, Inc.
Date Cleared
2023-07-27
(755 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
2 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.
3 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.
Device Description
The Rusch SoftSimplastic Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.
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K Number
K231924Device Name
EZ-IO Intraosseous Vascular Access System
Manufacturer
Teleflex Medical
Date Cleared
2023-07-25
(25 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases up to 24 hours. For patients ≥ 12 years old, the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.
Device Description
The EZ-IO Intraosseous Vascular Access System previously cleared with K202492 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).
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