FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
K Number: K081933
·
Decision Oct 3, 2008
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
3
Review Days
88
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Basic Information
- Device Name
- AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
- K Number
- K081933
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avalon Laboratories, LLC
- Date Received
- July 7, 2008
- Decision Date
- October 3, 2008
- 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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