FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENDERO MAX Delivery Catheter
K Number: K242644
·
Decision Dec 20, 2024
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
4
Review Days
108
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Basic Information
- Device Name
- SENDERO MAX Delivery Catheter
- K Number
- K242644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Okami Medical, Inc.
- Date Received
- September 3, 2024
- Decision Date
- December 20, 2024
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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