FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVA BALLOON THERMODILUTION INFUSION
K Number: K841640
·
Decision Aug 12, 1984
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
11
Review Days
114
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Basic Information
- Device Name
- NOVA BALLOON THERMODILUTION INFUSION
- K Number
- K841640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Nova Medical Specialties
- Date Received
- April 20, 1984
- Decision Date
- August 12, 1984
- Product Code
- DYG
- 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 |
|---|---|---|---|
| DYG | Catheter, Flow Directed | FDA class 2 | 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 |
| 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 |
| K812761 | FLOW-DIRECTED BALLOON THERMODILUTION | Nov 2, 1981 | Substantially Equivalent |