FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
K Number: K252707
·
Decision May 20, 2026
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
4
Review Days
266
Basic Information
- Device Name
- Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
- K Number
- K252707
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzhou Zenith Vascular SciTech Limited
- Date Received
- August 27, 2025
- Decision Date
- May 20, 2026
- 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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