FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTERIAL BLOOD FILTER BF-37
K Number: K802755
·
Decision Jan 7, 1981
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
95
Applicant Total
27
Review Days
65
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Basic Information
- Device Name
- ARTERIAL BLOOD FILTER BF-37
- K Number
- K802755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Delta Medical Industries
- Date Received
- November 3, 1980
- Decision Date
- January 7, 1981
- Product Code
- DTM
- 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 |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | FDA class 2 | Cardiovascular |
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Other Clearances by Delta Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K833884 | ISOTEC DISPOS. PRESSURE TRANSDUCER | Apr 17, 1984 | Substantially Equivalent |
| K840253 | ONE-WAY AIR VALVE | Apr 5, 1984 | Substantially Equivalent |
| K832470 | INFUSION PUMP | Feb 28, 1984 | Substantially Equivalent |
| K830389 | ACCU-RYNGE PUMP SP-250 | Sep 12, 1983 | Substantially Equivalent |
| K831750 | PM-3 | Jul 26, 1983 | Substantially Equivalent |
| K822761 | DELIVERY TUBE SET #2226 | Sep 30, 1982 | Substantially Equivalent |
| K820912 | PMS-2 PRESSURE MONITOR SEPARATOR | May 18, 1982 | Substantially Equivalent |
| K820482 | ACCU-RYNGE INSULIN PUMP #SP-250 | Mar 26, 1982 | Substantially Equivalent |
| K810068 | PEDIATRIC ARTERIAL BLOOD FILTER | Jan 22, 1981 | Substantially Equivalent |
| K803102 | ARTERIAL BUBBLE TRAP K-20 | Dec 22, 1980 | Substantially Equivalent |