FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Distal Access Catheter
K Number: K233205
·
Decision Dec 22, 2023
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
91
Applicant Total
3
Review Days
85
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Basic Information
- Device Name
- Distal Access Catheter
- K Number
- K233205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai Heartcare Medical Technology Co., Ltd.
- Date Received
- September 28, 2023
- Decision Date
- December 22, 2023
- 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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