FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECATH MULTI-PURPOSE ARTERIAL SURGER
K Number: K790444
·
Decision Jun 11, 1979
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
4
Applicant Total
35
Review Days
97
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Basic Information
- Device Name
- ELECATH MULTI-PURPOSE ARTERIAL SURGER
- K Number
- K790444
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Electro-Catheter Corp.
- Date Received
- March 6, 1979
- Decision Date
- June 11, 1979
- Product Code
- GBA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBA | Catheter, Balloon Type | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBA), ordered by most recent decision date.
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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 |