- Physicians Office Resource

BB004 BIB Catheter 8 3 8F
BIB® - 614389

Device Description

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Keep away from sunlight

Storage Environment Temperature - Degrees Celsius

45.00
5.00

Device Sizes

Length : 30.000 MM

Diameter (mm) : 8.000 MM

Length of catheter : 110.000 CM

Length : 30.000 MM
Diameter (mm) : 8.000 MM
Length of catheter : 110.000 CM

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NVM

Device Name: Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

Device Class: 2

Physical State: Comprised of a catheter body with two concentric distal inflatable balloons.

Definition: Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Used independently for dilation or dilatation of diseased peripheral vasculature to restore blood flow

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral vasculature exclusive of coronary arteries.

Regulation Number: 870.1250

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 04046964899690

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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