Linear 7.5Fr. 25cc IAB (with APA) (China)
Linear 7.5Fr. 25cc IAB (with APA) (China) - 0684-00-0478-02C
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 7.5 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
Product Codes
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 IdentifiersDevice Id: 10607567109312
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