FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
K Number: K260195
·
Decision Apr 23, 2026
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
209
Review Days
91
Basic Information
- Device Name
- Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
- K Number
- K260195
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- January 22, 2026
- Decision Date
- April 23, 2026
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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