- Physicians Office Resource

SC Super Compliant Occlusion Balloon Catheter
TRANSFORM - M003SSC03050

Device Description

A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Store in cool, dry, dark place.

Device Sizes

Balloon Outer Diameter: 3.0 Millimeter

Length: 5.0 Millimeter

Balloon Outer Diameter: 3.0 Millimeter
Length: 5.0 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: MJN

Device Name: Catheter, Intravascular Occluding, Temporary

Device Class: 2

Physical State: N/A

Definition: N/A

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: 870.4450

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 07613327004717

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

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