FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
K Number: K233201
·
Decision Mar 27, 2024
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
76
Applicant Total
50
Review Days
181
Basic Information
- Device Name
- MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
- K Number
- K233201
- 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
- September 28, 2023
- Decision Date
- March 27, 2024
- Product Code
- QJP
- 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 |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | FDA class 2 | Cardiovascular |
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