FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTERIAL BUBBLE TRAP
K Number: K801770
·
Decision Aug 7, 1980
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
27
Review Days
10
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Basic Information
- Device Name
- ARTERIAL BUBBLE TRAP
- K Number
- K801770
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Delta Medical Industries
- Date Received
- July 28, 1980
- Decision Date
- August 7, 1980
- 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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| K820482 | ACCU-RYNGE INSULIN PUMP #SP-250 | Mar 26, 1982 | Substantially Equivalent |
| K810068 | PEDIATRIC ARTERIAL BLOOD FILTER | Jan 22, 1981 | Substantially Equivalent |
| K802755 | ARTERIAL BLOOD FILTER BF-37 | Jan 7, 1981 | Substantially Equivalent |