← FDA Medical Device Classifications

Surgical Kit

PAX · f · Unknown

Classification

FDA Product Code
PAX
Device class
f
Regulation
Review panel
NE
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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