FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
K Number: K242676
·
Decision Feb 28, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
17
Applicant Total
4
Review Days
175
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Basic Information
- Device Name
- pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
- K Number
- K242676
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5600
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phenox Limited
- Date Received
- September 6, 2024
- Decision Date
- February 28, 2025
- Product Code
- POL
- 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 |
|---|---|---|---|
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | FDA class 2 | Neurology |
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