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Found 1262 results
510(k) Data Aggregation
(177 days)
92618
Re: K252297
Trade/Device Name: Toro 88 Superbore Catheter
Regulation Number: 21 CFR 870.1250
Contact:** | Ryan WalkerChief Operating Officer657-229-1108 |
| Regulation Number: | 21 CFR 870.1250
Secondary Classification Product Code* | DQY | Same as K240948 |
| Regulation Number | 21 CFR 870.1250
The Toro 88 Superbore Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Toro 88 Superbore Catheter is a variable stiffness, single lumen catheter designed to introduce interventional devices into the vasculature. The catheter shaft design includes stainless steel and nitinol wires and polymers of varying durometers. The catheter incorporates an internal lubricious liner to facilitate its advancement over a steerable guidewire or microcatheter. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a hub with Luer lock. The catheter is supplied sterile, for single use only.
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(260 days)
K251357**
Trade/Device Name: Esperance pHLO Aspiration System
Regulation Number: 21 CFR 870.1250
System
Common or Usual Name: Catheter, Thrombus Retriever
Classification: Class II, 21 CFR 870.1250
As part of the Esperance pHLO Aspiration System, the Esperance pHLO Aspiration Catheter with a compatible aspiration pump and the Esperance Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The device is supplied as a kit consisting of a single Esperance® pHLO Aspiration Catheter, the Esperance Aspiration Tubing Set, and an introducer sheath, which combined comprise the Esperance® pHLO Aspiration System.
The Esperance® pHLO Aspiration Catheter is single lumen, flexible, variable stiffness composite catheter. A hub is attached to the proximal end, facilitating attachment of accessories, and the passage of devices into the inner lumen of the catheter, and connection to ancillary devices such as a vacuum source. A polymer sleeve is also attached to the hub and provides a gradual reduction in stiffness from the hub to the catheter shaft, in order to act as a strain relief.
A radiopaque marker is located approximately 0.6mm from the distal end of the catheter to allow visibility under fluoroscopy. Beyond the radiopaque marker comprises the soft atraumatic tip of the catheter. The following components: inner liner(s), braid, coil and polymer jackets are a part of the internal construction of the catheter. The distal 100cm of the catheter's external surface has a hydrophilic coating for increased lubricity during use. The Esperance pHLO Aspiration Catheter is offered with effective lengths of 125cm and 135cm with an outer diameter (OD) of 6F (0.083", 2.1mm) and an inner diameter (ID) of 0.071" (1.8mm).
The Esperance® pHLO Aspiration System is a non-active, surgically invasive device intended for short term use within the neurovasculature. The finished catheter is supplied sterile in a hoop, pouch and shelf carton configuration complete with an introducer sheath, aspiration tubing, and Directions for Use (DFU).
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(271 days)
California 92106
Re: K251097
Trade/Device Name: V-DAC Catheter
Regulation Number: 21 CFR 870.1250
Neurovasculature
Regulatory Class: Class II
Product Codes: QJP, DQY
Regulation Number: 21 CFR 870.1250
Company* | Vesalio, Inc. | Stryker Neurovascular | Penumbra, Inc. |
| Classification | 21 CFR 870.1250
: Percutaneous Catheter | 21 CFR 870.1250: Percutaneous Catheter | 21 CFR 870.1250: Percutaneous Catheter
The V-DAC Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral and neurovascular systems.
The V-DAC Catheter consists of 1) Distal Access Catheter and 2) Peel-Away Introducer Sheath.
The V-DAC Catheter is a single lumen, coil-reinforced, flexible, variable stiffness composite catheter. The catheter distal shaft has an external hydrophilic coating aimed at reducing friction during use. The distal end of the catheter shaft is radiopaque for fluoroscopic visualization, and the proximal end contains a luer hub that allows the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. Complete dimensions of the catheter are included on the device label.
The Peel-Away Introducer is an accessory provided with the catheter to aid in the delivery of the catheter.
The V-DAC Catheter and a Peel-Away Introducer are packaged together, they are provided sterile, non-pyrogenic, and are intended for single use only.
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(220 days)
33401
Re: K251668
Trade/Device Name: SurfRider 13 Microcatheter
Regulation Number: 21 CFR 870.1250
** Percutaneous catheter
Classification: Class II
Product Code: QJP, KRA
Regulation: 870.1250
Class II | Class II |
| Product Code(s) | QJP, KRA | DQY, QJP, KRA | KRA, QJP |
| Regulation | 870.1250
, 870.1210 | 870.1250, 870.1210 | 870.1210, 870.1250 |
| Medical Specialty | Cardiovascular | Cardiovascular
The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature.
The SurfRider 13 Microcatheter is a single-lumen microcatheter with a gradual stiffness change from tip to proximal end, reinforced with a metal braid to facilitate delivery to distal vessels and to serve as a delivery path of contrast media, embolic agents and coils. The distal end has two radiopaque markers to facilitate fluoroscopic visualization, and two types of tips: a straight tip and a pre-shaped tip. The proximal end of the Microcatheter incorporates a standard luer adaptor to facilitate the attachment of accessories. The outer surface of the Microcatheter has a hydrophilic coating to increase lubricity. The Microcatheter is designed to be introduced over a steerable guidewire into the vasculature.
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(80 days)
Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
Regulation Number: 21 CFR 870.1250
Delivery System (C320LBBL48)
Common Name: Catheter Delivery System
Regulation Number: 21 CFR 870.1250
This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.
The C320LBB delivery system is composed of a single-use, disposable, fixed-shape catheter with integrated hemostasis valve, two integrated radiopaque marker bands at the distal segment and a dilator. These components are used together to provide a flexible and hemostatic conduit for insertion of intravascular devices into the right chambers of the heart.
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(178 days)
K251915**
Trade/Device Name: Amethyst HP PTA OTW 0.035" Catheter
Regulation Number: 21 CFR 870.1250
K251915**
Trade/Device Name: Amethyst HP PTA OTW 0.035" Catheter
Regulation Number: 21 CFR 870.1250
transluminal angioplasty catheter
Generic name: PTA Catheter
Regulation Number: 21 CFR 870.1250
The Amethyst HP PTA OTW 0.035" Catheter is indicated for:
- Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Amethyst HP PTA OTW 0.035" catheter is a balloon catheter consisting of an over the wire catheter with a non-compliant inflatable balloon fixed at the distal end of the tip. The balloons are designed to provide consistent balloon diameters and lengths at high pressures. A tapered tip positioned at distal of the balloon facilitates the advancement of the catheter to and through the stenosis. A Luer lock fitting (Y hub) at the proximal end allows connection with an inflation device. The catheter is a co-axial catheter with a balloon at the distal tip. One lumen is used for the inflation of the balloon and is accessed via the lateral port of the Y hub. The second lumen, start at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The balloon has two radiopaque markers to aid in positioning the balloon relative to stenosis. The balloon is dilated using the lateral port, at which the balloon opens to a known diameter at a specific pressure. The maximum recommended guide wire diameter is 0.035''. The catheter is supplied sterile and is intended for single use.
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(138 days)
K252417**
Trade/Device Name: Amplatzer Piccolo™ Delivery System
Regulation Number: 21 CFR 870.1250
Common Name: Catheter Delivery System
Classification Name: Catheter, Percutaneous (21 CFR 870.1250
The Amplatzer Piccolo™ Delivery System is indicated to facilitate the delivery of an Amplatzer Piccolo™ Occluder through the heart of a patient with a patent ductus arteriosus.
The Amplatzer Piccolo Delivery System is designed to facilitate the delivery of an Amplatzer Piccolo™ Occluder into a patent ductus arteriosus (PDA). The Amplatzer Piccolo Delivery System consists of a delivery catheter, loader, Tuohy-Borst hemostasis valve with extension tube and stopcock, and self-sealing hemostasis valve. The Amplatzer Piccolo Delivery System is available in a 4 Fr size with a usable length of 45 cm. The delivery system components have the following performance characteristics:
- Delivery catheter: Provides a pathway through which an occluder is delivered. The body of the catheter is radiopaque for visibility under fluoroscopy. The distal end of the catheter has a curve that is optimized to allow co-axial placement of the delivery catheter within the PDA. A curve indicator is located on the hub as an additional reference for the direction of the curvature.
- Tuohy-Borst hemostasis valve with extension tube and stopcock: Allows flushing of the delivery catheter and controls blood backflow.
- Loader: Introduces an occluder into the delivery catheter.
- Self-sealing hemostasis valve: Allows flushing of the loader and delivery catheter and controls blood backflow.
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(141 days)
Massachusetts 01002
Re: K252213
Trade/Device Name: Bendit17 Microcatheter
Regulation Number: 21 CFR 870.1250
microcatheter
- Classification Name: Catheter, percutaneous, neurovasculature
- Regulation: 21 CFR 870.1250
Technologies Ltd. | MicroVention, Inc. | MicroVention, Inc. | Same as predicate. |
| Regulation | 21 CFR 870.1250
| 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Same |
| Class | Class II | Class II | Class
The Bendit17 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices.
Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.
The Bendit®17 Microcatheter is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle.
The total working length of the Bendit®17 Microcatheter is 151 cm. It is comprised of two Nitinol hypo tubes that are connected at their distal ends, with proprietary laser-cut patterns along the 38 cm distal section. The laser cuts give the Bendit®17 Microcatheter its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 10 mm section is steerable and includes two radiopaque markers, one at the tip and a radiopaque band located 30 mm proximally from the tip. The distal portion of the catheter shaft (100 cm) is covered with a hydrophilic coating.
Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit®17 lumen can accommodate compatible guidewires (≤ 0.014 ''). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.
The Bendit®17 is compatible with the following types of therapeutic devices:
- Embolization particles with maximum particle size of 400 µm
- Coils with maximum coil wire size of 0.014''
- Stents/stent retrievers/intrasaccular flow disruption devices compatible with microcatheters with inner diameter of 0.017''
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(223 days)
Re: K251006
Trade/Device Name: NeVasc Aspiration System
Regulation Number: 21 CFR 870.1250
Thrombus Retriever
Regulatory Class: Class II
Product Code: NRY
Regulation Number: 21 CFR 870.1250
K251006 | K211654 |
| Company | Vesalio, Inc. | Penumbra, Inc. |
| Classification | 21 CFR 870.1250
: Percutaneous Catheter | 21 CFR 870.1250: Percutaneous Catheter |
| Product Code | NRY: Catheter
NeVasc Aspiration Catheter:
As part of the NeVasc Aspiration System, the NeVasc Aspiration Catheter with the Vesalio Aspiration Tubing Set and a compatible aspiration pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Vesalio Aspiration Tubing Set:
As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is indicated to connect the NeVasc Aspiration Catheter to a compatible aspiration pump.
The NeVasc Aspiration System consists of 1) NeVasc Aspiration Catheter, 2) Peel Away Introducer Sheath and 3) Vesalio Aspiration Tubing Set.
The NeVasc Aspiration Catheter is a single-lumen, reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Vesalio Aspiration Tubing Set. The catheter distal shaft has an external hydrophilic coating aimed at reducing friction during use. The distal end of the catheter shaft is radiopaque for fluoroscopic visualization, and the proximal end contains a luer hub that allows attachment of accessories for flushing and aspiration.
The peel-away introducer sheath is provided in the package to facilitate the insertion of the NeVasc Aspiration Catheter's distal tip into an appropriate vascular sheath.
The Vesalio Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to a rotating hemostasis valve (RHV) or the female luer hub of the NeVasc Aspiration Catheter. The other end of the tubing consists of a hose fitting to enable connection with an aspiration pump. A flow switch is connected in line to provide vacuum control.
The NeVasc Aspiration System is provided sterile, non-pyrogenic, and is intended for single use only.
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(122 days)
95008
Re: K252046
Trade/Device Name: Zoom System (Zoom 4S Catheter)
Regulation Number: 21 CFR 870.1250
- Percutaneous Catheter
Regulatory Class: II
Product Code: NRY
Regulation: 21 CFR 870.1250
Retriever
Classification Name: Percutaneous Catheter
Product Code: NRY
Regulation: 21 CFR 870.1250
Retriever
Classification Name: Percutaneous Catheter
Product Code: NRY
Regulation: 21 CFR 870.1250
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| FDA Product Classification | Class II Product Code: NRY 21 CFR 870.1250
The Zoom System, when used with the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well.
Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 4S, 35) Catheter and the Zoom 88 Large Distal Platform, the Zoom 88 Large Distal Platform Support, or the TracStar LDP Large Distal Platform to the Zoom Canister or Zoom DuoPort Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.
The Zoom 4S Catheter, a new catheter within the Zoom System, is a single lumen, braid and coil reinforced, variable stiffness catheter with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The Zoom 4S Catheter has a luer hub on the proximal end. The Zoom 4S Catheter is intended to be used in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus.
Dimensions of the Zoom 4S Catheter are included on the individual device label. The Zoom 4S Catheter is compatible with 0.035" or smaller guidewires. An additional support catheter may be used to assist in accessing the target vasculature. The Zoom 4S Catheter is compatible with guide sheaths having a minimum inner diameter of 0.071".
The Zoom 4S Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing (Zoom POD) are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 4S Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD are made of common medical grade polymers.
In addition to the accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the Zoom 4S Catheter.
- Guidewires
- Support/Diagnostic Catheters
- Introducer Sheaths
- Aspiration Pump*
- Capable of achieving pressure between -20inHg to max vacuum (-29 inHg)
- Airflow rating of 0 – 23 LPM
- IEC 60601-1 Compliant
*Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria. The Zoom Aspiration Pump is used with the Zoom Canister or Zoom DuoPort Canister.
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