FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ELECATH TORKFLOAT PACING PROBE
K Number: K850065
·
Decision Apr 10, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
35
Review Days
92
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Basic Information
- Device Name
- ELECATH TORKFLOAT PACING PROBE
- K Number
- K850065
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Electro-Catheter Corp.
- Date Received
- January 8, 1985
- Decision Date
- April 10, 1985
- Product Code
- DTB
- 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTB), ordered by most recent decision date.
BIOTRONIK ENDOCARDIAL PACING LEADS
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PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
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MODEL 5071 MYOCARDIAL PACING LEAD
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MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
FDA Class 3
·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 |
| K850324 | ELECATH OPEN TIP BIPOLAR PACING CATHETER | Mar 27, 1985 | Substantially Equivalent |
| K844682 | ELECATH CARDIAC OUTPUT COMPUTER | Mar 6, 1985 | Substantially Equivalent |