← FDA Medical Device Classifications

Headframe

OVC · Not classified · Unknown

Classification

FDA Product Code
OVC
Device class
Not classified
Regulation
Review panel
NE
Medical specialty
Unknown
Submission type
3
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Definition

To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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