FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
PureFlex Arterial Cannulae
K Number: K180979
·
Decision Nov 16, 2018
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
61
Review Days
217
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Basic Information
- Device Name
- PureFlex Arterial Cannulae
- K Number
- K180979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sorin Group Italia S.R.L.
- Date Received
- April 13, 2018
- Decision Date
- November 16, 2018
- 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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