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510(k) Data Aggregation
(30 days)
Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
Regulation Number: 21 CFR 870.1330
Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
Regulation Number: 21 CFR 870.1330
Tapered 40
- F-18 Flex SP
- F-18 DP 25
- F-18 Tapered 40
Device Classification: Class 2 per 21 CFR §870.1330
18 Flex SP• F-18 DP 25• F-18 Tapered 40 |
| Device Classification: | Class 2 per 21 CFR §870.1330
FMD Peripheral Guidewires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral use only.
The FMD Peripheral Guide Wire F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The FMD Peripheral Guide Wire F-14 and F-18 in this submission are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190 cm to 300 cm. The FMD Peripheral Guide Wire F-14 and F-18 with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The basic structure of the FMD Peripheral Guide Wire F-14 and F-18 consists of a stainless steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion of the guide wire is coated with PTFE coating, and the distal portion is coated with a hydrophilic coating. The FMD Peripheral Guide Wire F-18 DP 25 is available with a pre-shaped tip configuration. All other models are available in straight tip configuration.
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(114 days)
K253746**
Trade/Device Name: Enroute Transcarotid 0.014" Guidewire
Regulation Number: 21 CFR 870.1330
Transcarotid Guidewire
Common Name: Guidewire
Classification Name: Catheter Guidewire (21 CFR §870.1330
Manufacturer:** Lake Region Medical
510(k) Number: K160643
Regulatory Class: Class II (21 CFR §870.1330
The Enroute Transcarotid 0.014" Guidewire is intended for use in the peripheral vasculature, inclusive of the carotid artery.
The ENROUTE Transcarotid 0.014" Guidewire is a disposable medical device designed for single use only. It consists of a 95cm PTFE coated 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over approximately 9.5cm in a progressive fashion through a centerless grinding operation. The profile of this reduced section affords the product an area of reduced stiffness. The distal tip section is flattened to further reduce stiffness and enable the tip to be shaped. The distal section is covered with a 5cm platinum tungsten spring coil. This provides for greater visibility on x-ray equipment (radiopacity). A hydrophilic coating is applied to the distal section to enhance lubricity. The product is available in a straight configuration.
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(30 days)
95131
Re: K260537
Trade/Device Name: Willow 24 Guidewire
Regulation Number: 21 CFR 870.1330
Guidewire
Common Name: Wire, Guide, Catheter
Classification Name: Wire, Guide, Catheter, 21 CFR 870.1330
Willow 24 Guidewire (K260537) |
|---|---|---|
| Classification Name | Wire, Guide, Catheter, 21 CFR 870.1330
The Willow 24 Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Like the predicate device, the Willow 24 Guidewire is a single-use product with a shapeable tip, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The Willow 24 Guidewire comes in two stiffness profiles: Soft and Standard.
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(252 days)
215123,
China
Re: K252122
Trade/Device Name: DCwire Micro-guidewire
Regulation Number: 21 CFR 870.1330
Micro-guidewire
Common Name: Micro-guidewire
Classification Name: Wire, Guide, Catheter, 21 CFR 870.1330
Class II | Class II | Same |
| Product Code | MOF, DQX | DQX | MOF, DQX |
| Regulation Number | 21 CFR 870.1330
| 21 CFR 870.1330 | Same |
| Review Panel | Neurology, Cardiovascular | Cardiovascular | Neurology,
The DCwire Micro-guidewire is intended for general intravascular use, including neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature.
The DCwire™ Micro-guidewire is a single-use device with a shapeable tip, used to gain intravascular access and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral and neuro diagnostic and interventional procedures. The Micro-guidewire can be torqued to facilitate navigation through the vasculature.
DCwire™ Micro-guidewire comes in three stiffness profiles: Soft, Standard, and Support.
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(158 days)
Duesseldorf, NRW 40225
Germany
Re: K253262
Trade/Device Name: EmeryGlide
Regulation Number: 21 CFR 870.1330
Classification Name:** Wire, Guide, Catheter
Classification Panel: Cardiovascular
Regulation: 21 CFR 870.1330
EmeryGlide is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.
EmeryGlide™ is a sterile, disposable guidewire for the introduction and/or placement of diagnostic or interventional devices. EmeryGlide™ is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of EmeryGlide™ is marked with discrete ring markers for MRI and X-Ray visibility and comes in an angled configuration. EmeryGlide™ is supplied sterile and non-pyrogenic. EmeryGlide™'s diameter is 0.035" (0.89 mm).
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(28 days)
95131
Re: K260130
Trade/Device Name: Willow 18 Guidewire
Regulation Number: 21 CFR 870.1330
Guidewire
Common Name: Wire, Guide, Catheter
Classification Name: Wire, Guide, Catheter, 21 CFR 870.1330
Willow 18 Guidewire (K260130) |
|---|---|---|
| Classification Name | Wire, Guide, Catheter, 21 CFR 870.1330
The Willow 18 Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Like the predicate device, the Willow 18 Guidewire is a single-use product with a shapeable tip, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The Willow 18 Guidewire comes in two stiffness profiles: Soft and Standard.
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(220 days)
California 92614
Re: K252011
Trade/Device Name: CHIKAI Nexus petit
Regulation Number: 21 CFR 870.1330
asahi-intecc-us.com
Device Name: CHIKAI Nexus petit
Device Classification: Class II, 21 CFR § 870.1330
LTD. | Balt USA, LLC. | Abbott Vascular | Micro Therapeutics, Inc. |
| Regulation Number | 21 CFR 870.1330
This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The basic structure of the CHIKAI Nexus petit consists of a hybrid tapered core wire in which Ni-Ti alloy and stainless steel (SUS) is conjoined via Ni-Ti pipe. The distal part of the core wire is surrounded by the Pt-Ni (platinum-nickel) coil, soldered with Au-Sn (gold-tin) alloy. For the proximal coil, the joint section is covered by a tube made of Ni-Ti alloy. Within the tube, the stainless steel and Ni-Ti core wires are connected with ASAHI's proprietary stainless-steel coil, soldered with Au-Sn alloy and silver.
In addition, coatings are applied on the surface of the device. The distal coil section is coated with a polyurethane coating. The hydrophilic coating is applied from the distal tip, on top of the polyurethane coating, to the proximal shaft.
The maximum nominal outer diameter of the CHIKAI Nexus petit is 0.33 mm (0.013"). The diameter is tapered towards the distal tip with the nominal diameter of 0.16mm (0.006"). The CHIKAI Nexus petit's radiopaque distal tip (up to 8cm from the tip) enables the user to view the position of the tip under X-ray fluoroscopy.
The device is available in length of 220cm with tip-shape variations of Straight, Round-curve and J-shape design.
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(60 days)
Trade/Device Name:** Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Regulation Number: 21 CFR 870.1330
Trade/Device Name:** Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
The Splashwire Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:
J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 3.0 mm J Tip.
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(261 days)
: K251385**
Trade/Device Name: InQwire Super Stiff Guide Wire
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
The InQwire Super Stiff Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures. The InQwire Super Stiff Guide Wire is indicated for use in the peripheral vasculature and chambers of the heart, excluding the coronary arteries and cerebral vasculature.
The Merit InQwire Super Stiff guide wire consists of 0.032" and 0.035" outer diameter (OD) guidewire configurations with guidewire lengths of 80cm, 100cm, 150cm, 180cm and 260cm. The guidewire is provided in straight and J3mm with a range of flexible properties.
The Merit InQwire Super Stiff guide wire is composed of a stainless-steel core wire and a PTFE coated stainless steel coil. The guidewire is welded at the distal and proximal tip with each tip having a polished weld finish. The stainless-steel construction provides radiopacity. The guidewire is supplied sterile, non-pyrogenic and is intended for single patient use only.
The Merit InQwire Super Stiff guide wire is placed through a vascular access device and advanced under fluoroscopy to the desired location according to the planned procedure by the clinician. It is used to facilitate the placement of devices during diagnostic and interventional procedures within the peripheral vasculature and central circulatory system, excluding the coronary arteries and cerebral vasculature.
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(137 days)
K252674**
Trade/Device Name: Solo Pace Fusion System (SOLOFUSE1)
Regulation Number: 21 CFR 870.1330
K252674**
Trade/Device Name: Solo Pace Fusion System (SOLOFUSE1)
Regulation Number: 21 CFR 870.1330
System |
|---|---|
| Common / Usual Name | Catheter Guidewire |
| Classification Name | 21 CFR 870.1330
System |
|---|---|
| Common / Usual Name | Catheter Guidewire |
| Classification Name | 21 CFR 870.1330
Solo Pace Fusion is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Solo Pace Fusion can be used for temporary intracardiac pacing by transmitting an electrical signal from Solo Pace Control to the heart.
The Solo Pace Fusion System consists of the following components:
- Fusion Guidewire
- Fusion Ground Pad
- Fusion Connection Cable
- Solo Pace Control System, consisting of the following:
- Solo Pace Remote Control Module (RCM), packaged with the Fusion Guidewire, Fusion Ground Pad and Fusion Connection Cable
- Solo Pace External Pulse Generator (EPG) (sold separately)
The Fusion Guidewire is intended to deliver interventional devices into the heart and serve as the pacing conduit when used with the Solo Pace Control system. The Fusion Guidewire is made of stainless steel and includes a pre-shaped pigtail distal tip. The Fusion Guidewire has a diameter of 0.035" (0.89 mm) and a length of 275 cm. The Fusion Guidewire is supplied with a tip insertion tube to help advance the guidewire into a catheter. A PTFE coating covers the shaft for lubricity. The proximal 8mm is uncoated to allow connection of the Fusion Guidewire to the Fusion Connection Cable. The pigtail is coated with silicone for lubricity. The Fusion Guidewire is supplied sterile, non-pyrogenic and is intended for single use only.
The Fusion Ground Pad is a transcutaneous pad placed on the patient to serve as the anode terminal for unipolar pacing via a unique connection to the Fusion Connection Cable. The Ground Pad acts as the return electrode for the pacing signal delivered to the patient's heart through the Fusion Guidewire. The Ground Pad cable is 60 inches (1.5 m) long and the skin contacting surface area is 350 cm².
The Fusion Connection Cable connects the Fusion Guidewire and the Fusion Ground Pad to the Solo Pace Control System (EPG component) in a manner that ensures proper polarity. The Fusion Connection Cable is approximately 60 inches (1.5 m) long.
The Solo Pace Control System RCM is a single use sterile device supplied with the Solo Pace Fusion System. The Solo Pace RCM connects wirelessly with the EPG to allow physician control of the EPG in the sterile field.
The Solo Pace Control System EPG is a reusable, external pulse generator described in detail in its Instructions for Use (IFU). The Solo Pace Control IFU should be reviewed, in its entirety, prior to the use of the Solo Pace Fusion System. Solo Pace Control was cleared for use under K241781.
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