FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Artemis Neuro Evacuation Device
K Number: K171332
·
Decision Aug 14, 2017
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
90
Applicant Total
50
Review Days
98
Basic Information
- Device Name
- Artemis Neuro Evacuation Device
- K Number
- K171332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penumbra, Inc.
- Date Received
- May 8, 2017
- Decision Date
- August 14, 2017
- Product Code
- GWG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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