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510(k) Data Aggregation
K Number
K240917Device Name
Esperance 3+ Aspiration Catheter System
Manufacturer
Wallaby Medical
Date Cleared
2024-10-01
(181 days)
Product Code
NRY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Wallaby Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Device Description
The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has a tapered shaft with tapered inner diameter (ID) from 0.054'' (proximal) to 0.041'' (distal) and tapered outer diameter (OD) from 0.066'' (proximal) to 0.050'' (distal). It has five different working lengths: 120 cm, 133 cm, 145 cm, 153 cm, and 160 cm. The device is supplied as a kit with the Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.
The Esperance 3+ Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the neurovasculature.
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K Number
K231056Device Name
Esperance Distal Access Catheter
Manufacturer
Wallaby Medical
Date Cleared
2024-03-08
(330 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Wallaby Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Device Description
The Esperance® Distal Access Catheter is a single-use, single lumen, variable stiffness, composite catheter. The device includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, and 131 cm. The device is supplied with a peelable introducer and shaping mandrel. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.
The Esperance® Distal Access Catheter is a non-active, surgically invasive device intended for short term use within the vasculature.
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K Number
K232437Device Name
Paragon 8F Balloon Guide Catheter
Manufacturer
Wallaby Medical
Date Cleared
2023-10-13
(60 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Wallaby Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paragon 8F Balloon Guide Catheter is in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
Device Description
The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon inflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations.
The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.
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K Number
K223139Device Name
Wallaby 017 Micro Catheter
Manufacturer
Wallaby Medical
Date Cleared
2023-04-25
(203 days)
Product Code
KRA, DQY, QJP
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
Wallaby Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials such as contrast media as well as delivery of embolic coils.
Device Description
The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device is a microcatheter with an inner diameter (ID) of 0.017", designed with a working length of 150 cm. The device has three different tip configurations: straight (0°), 45°, 90°, and is steam shapeable by the user. The device is supplied as a kit with an introducer sheath, shaping mandrel, and mandrel card provided with a single catheter. The distal tip of the Wallaby 017 Micro Catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each microcatheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous vasculature.
The Wallaby 017 Micro Catheter is a non-active, surgically invasive device intended for limited duration use within the vasculature.
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K Number
K222603Device Name
6F Wallaby Long Sheath
Manufacturer
Wallaby Medical Inc
Date Cleared
2023-03-02
(185 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Wallaby Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Device Description
The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has an inner diameter (ID) of 0.088 inch and outer diameter (OD) of 0.105 inch designed with three different working lengths (80 cm, 90 cm, and 100 cm) and two different tip configurations (straight and multipurpose curve). The distal tip of the 6F Wallaby Long Sheath is visible under fluoroscopy and the distal shaft of the catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of the catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. The 6F Wallaby Long Sheath has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.
The 6F Wallaby Long Sheath is a non-active, surgically invasive device intended for short term use within the vasculature.
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K Number
K211697Device Name
Esperance Aspiration Catheter System
Manufacturer
Wallaby Medical
Date Cleared
2021-11-16
(166 days)
Product Code
NRY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Wallaby Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Esperance Aspiration Catheter with the Medela Dominant Flex Surgical Suction Pump and Wallaby Aspiration Tubing set is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - Ml and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Device Description
The Esperance Aspiration Catheter System is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device system includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, 125 cm, and 131 cm. The device is supplied as a kit with Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy. The Esperance Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the vasculature.
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K Number
K173711Device Name
Wallaby Avenir Coil System
Manufacturer
Wallaby Medical, Inc.
Date Cleared
2018-05-04
(151 days)
Product Code
HCG, KRD
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
Wallaby Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.
Device Description
The Wallaby Avenir Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are mechanically detached from the delivery pusher in serial manner until the aneurysm is occluded.
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