← FDA Medical Device Classifications

Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

QZK · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code
QZK
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
Review panel
CV
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Definition

Endovascular repair of thoracoabdominal and pararenal aortic lesions

Market data

Cleared 510(k) submissions
0
Registered establishments
2

Source

Authoritative
FDA Device Classification database
Machine
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