FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
COAXIAL BIPOLAR PACING ELECTRODE
K Number: K822239
·
Decision Oct 4, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
10
Review Days
68
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Basic Information
- Device Name
- COAXIAL BIPOLAR PACING ELECTRODE
- K Number
- K822239
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Burditt & Calkins-Siemens-Elema
- Date Received
- July 28, 1982
- Decision Date
- October 4, 1982
- 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 Burditt & Calkins-Siemens-Elema
| K Number | Device Name | ||
|---|---|---|---|
| K833519 | PULSE GENERATOR MODEL 688 | Jan 30, 1984 | Substantially Equivalent |
| K833155 | RAYDEN MEDICAL MINI PULSE VOLUME RECORD | Jan 26, 1984 | Substantially Equivalent |
| K830344 | SIEMENS-ELMA PULSE GENERATOR #718 | May 27, 1983 | Substantially Equivalent |
| K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR | Dec 30, 1982 | Substantially Equivalent |
| K823591 | AMEDA HAND BREAST PUMP | Dec 28, 1982 | Substantially Equivalent |
| K821712 | INFORMED REMOTE FIELD UNIT MODEL IFM1000 | Jul 26, 1982 | Substantially Equivalent |
| K803111 | ERECTAID | Jan 23, 1981 | Substantially Equivalent |
| K802607 | TERPERATUR SENSING DEVICE | Nov 19, 1980 | Substantially Equivalent |
| K760787 | LIBERATOR/STROLLER | Oct 22, 1976 | Substantially Equivalent |