FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
CARDIAC PACEMAKER C4000, C1000 SER.
K Number: K791921
·
Decision Oct 26, 1979
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
19
Review Days
31
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Basic Information
- Device Name
- CARDIAC PACEMAKER C4000, C1000 SER.
- K Number
- K791921
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Vitatron Medical BV
- Date Received
- September 25, 1979
- Decision Date
- October 26, 1979
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
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OPUS S MODEL 4121 AND 4124 PACEMAKERS
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PIKOS LP 01, PIKOS LP E01
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ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
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MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
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FDA Class 3
·Cardiovascular
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Vitatron Medical BV
| K Number | Device Name | ||
|---|---|---|---|
| K854790 | CERYX PACEMAKER MODELS 114, 314 & 614 | Aug 28, 1986 | Substantially Equivalent |
| K844484 | HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA | Jul 24, 1985 | Substantially Equivalent |
| K844483 | TP 1 | Apr 19, 1985 | Substantially Equivalent |
| K844485 | CERYX6, 611, CERYX 3 311 & CERYX 1 111 | Apr 19, 1985 | Substantially Equivalent |
| K840668 | ELECTRODE PACEMAKER, PERM & TEMP | Sep 24, 1984 | Substantially Equivalent |
| K831859 | PACEMAKER PROGRAMMER #2032 | Oct 27, 1983 | Substantially Equivalent |
| K831860 | GENERATOR, PULSE, PACEMAKER #532 | Oct 27, 1983 | Substantially Equivalent |
| K810928 | ENDOCARDIAL ELECTRODE | Jul 2, 1981 | Substantially Equivalent |
| K791920 | CARDIAC PACEMAKER P4000 SER. & P1000 | Nov 29, 1979 | Substantially Equivalent |
| K791380 | VA 1000 | Sep 19, 1979 | Substantially Equivalent |