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510(k) Data Aggregation
K Number
K213771Device Name
Merlin Aspiration System
Manufacturer
MIVI Neurovascular, Inc.
Date Cleared
2022-01-27
(56 days)
Product Code
DXE, QEZ
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
MIVI Neurovascular, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
· Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system.
· High Flow Tubing
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.
Device Description
The Merlin Aspiration System is comprised of two devices:
- Merlin Aspiration Catheter
- High Flow Tubing
The Merlin Aspiration Catheter is introduced through a guide catheter or long sheath into the peripheral vasculature and guided over a guidewire to the site of primary occlusion. The Merlin Aspiration Catheter is used in conjunction with an aspiration pump, which is connected to High Flow Tubing. These devices are visible under fluoroscopy.
Merlin Aspiration Catheter
The Merlin Aspiration Catheter consists of single lumen, coiled construction, variable stiffness shaft with radiopaque markers on distal and proximal end of the catheter portion for angiographic visualization. The Merlin Aspiration Catheter is identical in design to the MIVI Q Distal Access Catheter (K192558).
High Flow Tubing
The MIVI High Flow Tubing is a sterilized and disposable (onetime use) product consisting of high-pressure PVC tubing with end fittings and an on/off switch. The MIVI High Flow Tubing connects an aspiration pump to a reperfusion catheter, providing a means for introducing vacuum during procedures. The MIVI High Flow Tubing has a flow valve that allows the physician to start and stop the flow of aspiration.
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K Number
K192558Device Name
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
Manufacturer
MIVI Neurovascular
Date Cleared
2020-04-06
(202 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MIVI Neurovascular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Q 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, coronary and neuro vascular systems.
Device Description
The MIVI Q Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The catheter contains a pin vise threaded on the control wire, which may be used to advance the catheter.
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