- Physicians Office Resource

Balloon Catheter 6225 Attain Clarity
ATTAIN CLARITY™ - 6225

Device Description

A flexible tube with specific tip configurations designed to enter the left or right ventricle to perform diagnostic haemodynamic/angiographic procedures with contrast media. The distal tip may have an end hole and/or several side holes. The tube is introduced into a peripheral blood vessel and its distal tip is placed in the left or right ventricle according to the desired ventriculography. Left ventriculography is used to assess impairment of the left ventricle, the presence of ventricular aneurysms or septal defects, or to assess the mitral valve. Right ventriculography is used mostly to asses congenital heart disease. This is a single-use device.

Environmental Conditions

Storage Environment Temperature - Degrees Fahrenheit

104.00
N/A

Device Sizes

Inflation volume maximum 2.75 ml

Usable length 90 cm

Inflation volume nominal 2.5 ml

Maximum guidewire diameter 0.018 in (0.46 mm)

Guide catheter minimum inner diameter 1.9 mm (5.7 Fr)

Balloon diameter at nominal 13 mm

Inflation volume maximum 2.75 ml
Usable length 90 cm
Inflation volume nominal 2.5 ml
Maximum guidewire diameter 0.018 in (0.46 mm)
Guide catheter minimum inner diameter 1.9 mm (5.7 Fr)
Balloon diameter at nominal 13 mm

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DQY

Device Name: Catheter, Percutaneous

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: 870.1250

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 00643169530102

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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