FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPS Locator 3D Delivery Catheter
K Number: K250147
·
Decision Aug 22, 2025
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
2
Review Days
213
Basic Information
- Device Name
- CPS Locator 3D Delivery Catheter
- K Number
- K250147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Centerpoint Systems
- Date Received
- January 21, 2025
- Decision Date
- August 22, 2025
- 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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Other Clearances by Centerpoint Systems
| K Number | Device Name | ||
|---|---|---|---|
| K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 | Jun 28, 2019 | Substantially Equivalent |