FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K Number: K844003
·
Decision Dec 27, 1984
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
35
Review Days
76
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Basic Information
- Device Name
- ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
- K Number
- K844003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Electro-Catheter Corp.
- Date Received
- October 12, 1984
- Decision Date
- December 27, 1984
- Product Code
- LDF
- 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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
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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 |