FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAIM CORONARY SINUS FLOW CALCULATOR
K Number: K842831
·
Decision Aug 27, 1984
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
35
Review Days
38
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BAIM CORONARY SINUS FLOW CALCULATOR
- K Number
- K842831
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Electro-Catheter Corp.
- Date Received
- July 20, 1984
- Decision Date
- August 27, 1984
- Product Code
- DXG
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXG), ordered by most recent decision date.
Argos Infinity (Rev. 1.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
VitalStream ART Connect; VitalStream-Hemo
FDA 510(k)
FDA Class 2
·Cardiovascular
Cogent Hemodynamic Monitoring System; Cogent HMS
FDA 510(k)
FDA Class 2
·Cardiovascular
Hypotension Decision Assist Model HDA-OR2
FDA 510(k)
FDA Class 2
·Cardiovascular
PulsioFlex Monitoring System with ProAQT Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
EV1000 Clinical Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Electro-Catheter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934785 | MULTIPACE | Jul 27, 1995 | Substantially Equivalent |
| K933450 | CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION | Apr 19, 1995 | Substantially Equivalent |
| K943257 | TIP DEFLECTOR (GENESIS) | Apr 19, 1995 | Substantially Equivalent |
| K933451 | OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION | Apr 19, 1995 | Substantially Equivalent |
| K934787 | SILICORE SEMI-FLOATER | Feb 24, 1995 | Substantially Equivalent |
| K874154 | ELECATH(R) TRANSESOPHAGEAL PACING CATHETER | Apr 29, 1988 | Substantially Equivalent |
| K854511 | ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET | Feb 10, 1986 | Substantially Equivalent |
| K854975 | ELECATH PULSATILE PERFUSION PUMP | Jan 15, 1986 | Substantially Equivalent |
| K850065 | ELECATH TORKFLOAT PACING PROBE | Apr 10, 1985 | Substantially Equivalent |
| K850324 | ELECATH OPEN TIP BIPOLAR PACING CATHETER | Mar 27, 1985 | Substantially Equivalent |