FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DELTA D-750 THERMAFLOW
K Number: K790406
·
Decision Nov 13, 1979
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
27
Review Days
260
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Basic Information
- Device Name
- DELTA D-750 THERMAFLOW
- K Number
- K790406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Delta Medical Industries
- Date Received
- February 26, 1979
- Decision Date
- November 13, 1979
- Product Code
- DTZ
- 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 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 |
| K802755 | ARTERIAL BLOOD FILTER BF-37 | Jan 7, 1981 | Substantially Equivalent |