FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
APC IMPLANTABLE PACING LEAD-FLANGE #3260
K Number: K810397
·
Decision May 15, 1981
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
14
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- APC IMPLANTABLE PACING LEAD-FLANGE #3260
- K Number
- K810397
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Pacemaker Corp.
- Date Received
- February 18, 1981
- Decision Date
- May 15, 1981
- 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
FDA 510(k)
FDA Class 3
·Cardiovascular
PERMANENT PACING LEAD, MODEL PY2
FDA 510(k)
FDA Class 3
·Cardiovascular
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
FDA 510(k)
FDA Class 3
·Cardiovascular
MODEL 5071 MYOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
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 |
| K810396 | APC IMPLANTABLE PACING LEAD, TINED #3262 | May 15, 1981 | 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 |
| 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 |
| K791955 | UNIFOCAL 1 UNIPOLAR DEMAND R WAVE | Nov 27, 1979 | Substantially Equivalent |