FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
FLOW-DIRECTED BALLOON THERMODILUTION
K Number: K812761
·
Decision Nov 2, 1981
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
24
Applicant Total
11
Review Days
32
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Basic Information
- Device Name
- FLOW-DIRECTED BALLOON THERMODILUTION
- K Number
- K812761
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Nova Medical Specialties
- Date Received
- October 1, 1981
- Decision Date
- November 2, 1981
- Product Code
- KRG
- 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 |
|---|---|---|---|
| KRG | Programmer, Pacemaker | FDA class 3 | Cardiovascular |
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Other Clearances by Nova Medical Specialties
| K Number | Device Name | ||
|---|---|---|---|
| K872770 | DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. | Oct 15, 1987 | Substantially Equivalent |
| K860526 | NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH | May 2, 1986 | Substantially Equivalent |
| K853625 | NOVA ARTERIAL EMBOLECTOMY CATHETER | Jan 15, 1986 | Substantially Equivalent |
| K840009 | NOVA 12 CARDIAC OUTPUT COMPUTER | Aug 22, 1984 | Substantially Equivalent |
| K841639 | NOVA BALLOON THERMODILUTION CATH. | Aug 12, 1984 | Substantially Equivalent |
| K841640 | NOVA BALLOON THERMODILUTION INFUSION | Aug 12, 1984 | Substantially Equivalent |
| K834036 | HEPARIN COATED BALLOON THERMODILU | Jan 10, 1984 | Substantially Equivalent |
| K834037 | HEPARIN COATED BALLOON THERMODILU | Jan 10, 1984 | Substantially Equivalent |
| K832287 | NOVA BALLOON THERMODILUTION INFUSION | Oct 19, 1983 | Substantially Equivalent |
| K822806 | BALLOON WEDGE PRESSURE, ANGIOGRAPHIC | Nov 1, 1982 | Substantially Equivalent |