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510(k) Data Aggregation
K Number
K190338Device Name
046 Zenith Flex
Manufacturer
InNeuroCo, Inc
Date Cleared
2019-08-02
(169 days)
Product Code
NRY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
InNeuroCo, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zenith Flex Aspiration System, including the 046 Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated 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 intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
Device Description
The InNeuroCo 046 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Nitinol to provide support. The proximal section has an embedded nitinol flat wire cross coil that transitions to a nitinol round wire sinqle coil in the distal end. It has a radiopaque Platinum/Iridium marker band on the distal end. The 046 Zenith Flex Catheter is available with an internal diameter of 0.046 inches. The outer diameter is 0.058 inches along the proximal shaft and 0.056 inches at the distal tip. The 046 Zenith Flex Catheter is available in two working lengths: 153 cm, and 160 cm. The 046 Zenith Flex Catheter has a PTFE-lined lumen to reduce friction as it travels over a guidewire. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and peel-away introducer. The 046 Zenith Flex Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
The other system components are: the Aspiration Tubinq Set and the VC-701 Cliq Aspirator Pump. The Aspiration Tubing Set is provided sterile and is intended for single use only. The aspiration pump is provided non-sterile and is used in multiple procedures.
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K Number
K172167Device Name
Zenith Flex System
Manufacturer
InNeuroCo, Inc.
Date Cleared
2018-04-19
(275 days)
Product Code
NRY, DTL, DYB
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
InNeuroCo, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute 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 intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
Device Description
The Zenith Flex System consists of the Zenith Flex Catheter, the VC-701 Cliq Aspiration Pump and the Aspiration Tubing Set. The InNeuroCo Zenith Flex Catheter is a variable stiffness catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/Iridium marker band on the distal end. The distal 25 cm of the Zenith Flex Catheter has a hydrophilic coating. The Zenith Flex Catheter is available with an internal diameter of 0.0715 inch. The outer diameter is of 0.0850 inch in the proximal section, and tapers to a nominal of 0.082 inch in the distal section. The Zenith Flex Catheter is available in three working lengths: 115 cm, 125 cm, and 132 cm. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and two peel-away Introducers and a Scout introducer. The Scout may be used to introduce the Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy. The Zenith Flex Catheter is supplied sterile, nonpyrogenic, and intended for single use only. The off-the-shelf aspiration pump is provided non-sterile.
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K Number
K173709Device Name
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
Manufacturer
InNeuroCo, Inc
Date Cleared
2018-01-26
(53 days)
Product Code
DQY, DOY, DTL, DYB
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
InNeuroCo, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Device Description
The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.
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K Number
K172468Device Name
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
Manufacturer
InNeuroCo, Inc
Date Cleared
2017-12-06
(113 days)
Product Code
DQY, DTL, GCC
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
InNeuroCo, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.
Device Description
The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/lridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The 091 Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.
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K Number
K171672Device Name
065 Zenith, 074 Zenith
Manufacturer
InNeuroCo, Inc
Date Cleared
2017-10-19
(135 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
InNeuroCo, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zenith is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Device Description
The InNeuroCo Zenith product consists of a catheter, a hemostasis valve, two split sheath introducers, and a Scout introducer. The Zenith catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith catheter has a radiopaque Platinum/lridium marker band on the distal end. The Zenith product line is available in two internal diameters: 0.065 inches and 0.074 inches. The 0.065 catheter has a tapered design and is 0.079 inches outer diameter in the distal end and a 0.081 inches outer diameter in the proximal end. The 0.074 catheter has a nominal outer diameter of 0.086 inches. There are three working lengths available: 115 cm, 125 cm, and 132 cm in either diameter. The Zenith catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith catheter is inserted through a quide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and two split sheath introducers. There is another introducer, named Scout, which provides support to the Zenith catheter while tracking to target site. The Zenith product line is supplied sterile, nonpyrogenic, and intended for single use only.
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K Number
K161262Device Name
Super Distal Access (SDA)
Manufacturer
INNEUROCO, INC
Date Cleared
2016-09-19
(137 days)
Product Code
DQY, DTL
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
INNEUROCO, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Device Description
The Super Distal Access (SDA) is a single lumen, variable stiffness catheter and has a shaft reinforced with a Stainless Steel/Nitinol coil. The SDA has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a maximum outer diameter of 0.084 inches. It has a tapered design that includes a nominal inner diameter of 0.062 inches in the distal end and 0.068 inches in the proximal end. There are three working lengths available: 115 cm, 125 cm, and 135 cm. The Super Distal Access has a PTFE-lined lumen in the distal end a Polyimide/PTFE-lined lumen in the proximal end. The catheter is flexible and has a hydrophilic coating. The SDA is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The SDA is supplied sterile, non-pyrogenic, and intended for single use only.
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