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510(k) Data Aggregation
K Number
K222341Device Name
Arrow 0.2 Micron Flat Filter, GVS
Manufacturer
Arrow International, LLC
Date Cleared
2023-02-13
(194 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K210983Device Name
BD Epilor Syringe
Manufacturer
Becton Dickinson and Company
Date Cleared
2022-05-19
(413 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD Epilor™ syringes are intended for use with either air or liquid in conjunction with an epidural needle for identifying the epidural space. These types of syringes facilitate the "loss of resistance" technique for identifying the epidural space by reducing subjectivity when locating this space and the potential for complications when administering epidural anesthesia to patients. Not for spinal applications. These devices are intended for adult and pediatric patients.
Device Description
The subject BD Epilor™ (Loss of Resistance Syringe) is used in various types of epidural anesthesia procedures. The purpose of this syringe is to help the anesthesiologist locate the epidural space prior to administering either single shot or continuous epidural anesthesia. The syringe assembly consists of a lubricated polypropylene barrel imprinted with a graduated scale, a polypropylene plunger rod, and a silicone rubber stopper which is a double-ribbed to prevent leakage. BD Epilor ™ is used in conjunction with an epidural needle for the purpose of identifying the epidural space. BD Epilor™ syringes are available in 7ml sizes and supplied in plastic configurations and as sterile or Bulk Non-Sterile.
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K Number
K201356Device Name
Plastic LOR Syringe
Manufacturer
Jiangsu Caina Medical Co., Ltd
Date Cleared
2021-02-12
(267 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged, and as part of a sterile kit.
Device Description
The Plastic LOR syringe is a piston syringe of three pieces. It consists of barrel, plunger and piston. The barrel is available with Luer slip, NRFit lock, NRFit Slip male connector. The Plastic LOR syringe is provided in combinations of four connectors and four syringe capacities (5ml, 7ml, 10ml, 20ml). The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile will be supplied to Anesthetic Conduction Kit manufacturers to be sterile and packaged into kit. The Plastic LOR syringe is a single use device which will be supplied as sterile individually packaged and the non-sterile bulk packed. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the s helf life of five years.
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K Number
K202699Device Name
E-Cath STIM acc. Tsui
Manufacturer
PAJUNK GmbH Medizintechnologie
Date Cleared
2020-12-29
(104 days)
Product Code
CAZ, BSO, BSP
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The E-Cath STIM acc. Tsui System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle removal, to assist the physician pinpoint conduction catheter placement, an electrical stimulus can be applied to the conduction catheter tip via the catheter adapter.
The E-Cath STIM acc. Tsui System is contraindicated for the epidural space.
Device Description
The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula, E-Cath catheter, locking cap.
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K Number
K190345Device Name
VPC
Manufacturer
Pajunk GmbH Medizintechnologie
Date Cleared
2019-05-16
(91 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indication for Use: The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of Resistance Syringe is intended for use in conjunction with an epidural needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration.
The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
Device Description
The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers. It consists of a Barrel and Plunger. It has ISO 80369-6 NRFit™ and ISO 80369-7 LUER connectivity. The markings area is 0ml - 10ml and the priming volume is 10ml.
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K Number
K161075Device Name
Arrow Epidural Catheter Kit
Manufacturer
TELEFLEX MEDICAL, INC.
Date Cleared
2016-10-04
(169 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Device Description
The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.
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K Number
K153652Device Name
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
Manufacturer
TELEFLEX INC.
Date Cleared
2016-06-21
(183 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Device Description
The Arrow® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set features a wire reinforced, polyurethane body with centimeter markings to facilitate placement for continuous plexus and peripheral nerve blocks. The catheter includes a SnapLock™ adapter to enable infusion of medications, and a stylet for enhanced maneuverability. Procedural trays also include a stimulating or non-stimulating plexus block needle, and other procedural components.
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K Number
K143581Device Name
Arrow Epidural Catheter Kit
Manufacturer
Teleflex Medical, Inc.
Date Cleared
2015-06-26
(190 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arrow Epidural Catheter kit permits access to the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Device Description
The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.
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K Number
K122690Device Name
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
Manufacturer
ARROW INTERNATIONAL, INC.
Date Cleared
2012-12-21
(108 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of single-shot peripheral nerve block anesthesia or analgesia using medical imaging devices.
Device Description
The Arrow UltraQuik Peripheral Nerve Block (PNB) Needle is a single shot needle which is comprised of a cannula, hub, and fluid extension tube with female luer fitting. The single shot needles are available in various gauges, lengths, and point styles. These include:
- Gauge
- 20 Ga (Touhy only)
- 21 to 24 Ga
- Lengths
- 35 mm to 150 mm
- Point style
- Bevel tip
- Pencil point
- Touhy tip
- Cannula echogenicity
- The cannula is naturally echogenic but the addition of grooves on the cannula enhance the echogenicity
The UltraQuik may be used with medical imaging, i.e., ultrasound to assist in needle tip location.
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K Number
K110053Device Name
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
Manufacturer
SMITHS MEDICAL ASD, INC.
Date Cleared
2012-09-14
(616 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Product Code :
CAZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible CorrectInject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use.
The CorrectInject™ Catheter Connector is intended for use with an epidural anesthesia catheter and CorrectInject™ compatible components for the injection of local or regional anesthetics, narcotics or other medications indicated for injection into the epidural space.
The CorrectInject™ Syringe is intended for use with CorrectInject™ compatible components for the injection of medications.
The CorrectInject™ anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid when used with CorrectInject™ compatible components.
The CorrectInject™ filter needle is intended to draw up medication when using the CorrectInject™ Syringe.
The CorrectInject™ white transport cap is intended to fit the CorrectInject™ syringe.
The CorrectInject™ yellow cap is intended to fit the female side of the CorrectInject™ catheter connector or CorrectInject™ filter.
Device Description
The CorrectInject™ System specially designed non-Luer taper aids in preventing a standard Luer taper device from connecting or delivering a medication by the wrong route of administration.
The objective of the CorrectInject™ Taper system is to provide a non-Luer style, safety connection system that will help reduce the risk of misconnection.
The CorrectInject™ Taper system is intended to connect and be used solely with the components of the CorrectInject™ Safety System. The CorrectInject™ Safety System is intended to deliver medication to epidural and neuraxial locations.
CorrectInject™ Safety System components are considered not to be effectively connected if any of the following apply:
- Attachment to Luer components that requires the use of excessive force, torque, time or manipulation
- Physical resistance to attachment to Luer components beyond that defined in ISO 594-1, ISO 594-2 and BS EN 1707
- If an attachment is made to a standard Luer component, this attachment is non-functional as indicated by leakage per ISO 594-2, section 4.2 and BS EN 1707 section 4.2
The term "effectively connected" is defined as the ability to assemble linearly with normal clinical assembly force, or securely assemble together CorrectInject™ Safety System components using equivalent force, torque and technique, and resulting in a physically secure and functional assembly as defined by ISO 594 or BS EN 1707. The term "attachment" means to assemble such components that results in an assembly that may, or may not, be physically secure but is not functional as defined by ISO 594-1, ISO 594-2 and BS EN 1707.
The CorrectInject™ Safety System is designed to function in a similar manner as currently available Luer epidural systems. The locking components are attached together with a twisting motion the same as current Luer lock connectors. The difference in this system is that the interconnection taper is not a standard Luer taper (per ISO 594 Parts 1 &2). This CorrectInject™ Safety System is color-coded yellow for a neuraxial system.
The design consists of several unique pieces:
1) Epidural Catheter Connector
2) CorrectInject™ Syringe
3) Filter
4) Filter Needle Assembly
5) Caps
6) CorrectInject™ non-Luer epidural label
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