CATH MUS0130069X6 CPD ULTRA US 9F UL950

CATH MUS0130069X6 CPD ULTRA US 9F UL950
MO.MA ULTRA - MUS0130069X6

Device Description

An assembly of devices intended to provide cerebrovascular embolic protection during carotid artery angioplasty and stenting procedures. It is available in various configurations and typically includes a sheath/catheter(s), intravascular balloon(s), guidewire, and extracorporeal valves/filters. The assembly is introduced into an artery percutaneously and used to produce blockage of blood through balloon inflation, typically at the carotid bifurcation and internal carotid artery to prevent distal embolization by particulate debris/thrombus and allow removal of debris/thrombus by blood filtration or aspiration. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).

Device Sizes

9 F Minimum Recommended Introducer Sheath

0.083 IN Working Channel Diameter

9 F Minimum Recommended Introducer Sheath
0.083 IN Working Channel Diameter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NTE

Device Name: Temporary Carotid Catheter For Embolic Capture

Device Class: 2

Physical State: N/A

Definition: This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1250

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 08033477090719

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A