FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
UNIFOCAL 2-UNIPOLAR & BIPOLAR
K Number: K792199
·
Decision Nov 27, 1979
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
460
Applicant Total
14
Review Days
26
Basic Information
- Device Name
- UNIFOCAL 2-UNIPOLAR & BIPOLAR
- K Number
- K792199
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN PACEMAKER CORP.
- Date Received
- November 1, 1979
- Decision Date
- November 27, 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
FDA 510(k)
FDA Class 3
·Cardiovascular
OPUS S MODEL 4121 AND 4124 PACEMAKERS
FDA 510(k)
FDA Class 3
·Cardiovascular
PIKOS LP 01, PIKOS LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by AMERICAN PACEMAKER CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K821791 | EXTERNAL PULSE GENERATOR - EV4542 | Jul 6, 1982 | Substantially Equivalent |
| K812830 | APC IMPLANTABLE PACING LEAD | Jan 18, 1982 | Substantially Equivalent |
| K812807 | APC IMPLANTABLE PACING LEADS | Jan 18, 1982 | Substantially Equivalent |
| K810398 | APC IMPLANTABLE PACING LEAD, MODEL 3266 | May 15, 1981 | Substantially Equivalent |
| K810399 | APC IMPLANTABEL PACING LEAD, MODEL 3264 | May 15, 1981 | Substantially Equivalent |
| K810396 | APC IMPLANTABLE PACING LEAD, TINED #3262 | May 15, 1981 | Substantially Equivalent |
| K810397 | APC IMPLANTABLE PACING LEAD-FLANGE #3260 | May 15, 1981 | Substantially Equivalent |
| K810121 | UNIFOCAL 3 | Feb 23, 1981 | Substantially Equivalent |
| K800746 | UNIFOCAL VP, MODELS 7501 AND 7502 | Dec 16, 1980 | Substantially Equivalent |
| K800379 | BIFOCAL 2 8200 SERIES (A,B C,D) | Sep 26, 1980 | Substantially Equivalent |