Linear 7.5Fr. 25cc IAB with Accessories, US Only

Linear 7.5Fr. 25cc IAB with Accessories, US Only
Linear 7.5Fr. 25cc IAB with Accessories, US Only - 0684-00-0478-01U

A flexible, balloon-tipped, tube that is placed in the aorta distal to the aortic valve to augment the heart's pumping capability. It is typically introduced percutaneously via one of the femoral arteries and advanced to the descending thoracic aorta using fluoroscopic imaging guidance. Once positioned, an external pump alternately inflates and deflates the balloon in a cycle counter to the cardiac cycle (counter pulsation), facilitating ejection during systole and limits regurgitation during diastole. It is used to treat several cardiovascular conditions, e.g., after open-heart surgery, cardiogenic shock, intractable angina, or to reduce myocardial conditions. This is a single-use device.

No Data Available

• Catheter Gauge: 7.5 French

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: DSP

Device Name: System, Balloon, Intra-Aortic And Control

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: 870.3535

Third Party Flag: N

Medical Specialty: CV

Device Id: 10607567109480

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