FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
PEDIATRIC ARTERIAL CANNULA
K Number: K023251
·
Decision Dec 4, 2002
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
6
Review Days
65
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Basic Information
- Device Name
- PEDIATRIC ARTERIAL CANNULA
- K Number
- K023251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polystan A/S
- Date Received
- September 30, 2002
- Decision Date
- December 4, 2002
- 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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Other Clearances by Polystan A/S
| K Number | Device Name | ||
|---|---|---|---|
| K013038 | SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 | Aug 14, 2002 | Substantially Equivalent |
| K022281 | SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 | Aug 6, 2002 | Substantially Equivalent |
| K980974 | SAFE MINI | Oct 13, 2000 | Substantially Equivalent |
| K953976 | SAFE MICRO | Feb 4, 1997 | Substantially Equivalent |
| K912082 | SAFE II | Dec 4, 1991 | Substantially Equivalent |