FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS
K Number: K905312
·
Decision Jan 15, 1991
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
3
Review Days
48
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Basic Information
- Device Name
- DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS
- K Number
- K905312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Baxter Bentley Laboratories, Inc.
- Date Received
- November 28, 1990
- Decision Date
- January 15, 1991
- 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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