FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Penumbra System (Reperfusion Catheter RED 72)
K Number: K242104
·
Decision Feb 13, 2025
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
96
Applicant Total
50
Review Days
210
Basic Information
- Device Name
- Penumbra System (Reperfusion Catheter RED 72)
- K Number
- K242104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penumbra, Inc.
- Date Received
- July 18, 2024
- Decision Date
- February 13, 2025
- Product Code
- NRY
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | FDA class 2 | Cardiovascular |
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