FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ARCOBIOLITH PACEMAKER MODEL
K Number: K780776
·
Decision Oct 3, 1978
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
460
Applicant Total
21
Review Days
148
Basic Information
- Device Name
- ARCOBIOLITH PACEMAKER MODEL
- K Number
- K780776
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- ARCO MEDICAL PRODUCTS CO.
- Date Received
- May 8, 1978
- Decision Date
- October 3, 1978
- 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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MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
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NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
FDA 510(k)
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·Cardiovascular
Other Clearances by ARCO MEDICAL PRODUCTS CO.
| K Number | Device Name | ||
|---|---|---|---|
| K802588 | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. | Nov 19, 1980 | Substantially Equivalent |
| K801806 | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE | Sep 9, 1980 | Substantially Equivalent |
| K801241 | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. | Jun 30, 1980 | Substantially Equivalent |
| K800837 | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR | Jun 30, 1980 | Substantially Equivalent |
| K800838 | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. | Jun 4, 1980 | Substantially Equivalent |
| K800326 | ARCOLITH 3021-CARDIAC PULSE GENERATOR | Mar 17, 1980 | Substantially Equivalent |
| K792216 | ARCOLITH 2100-CARDIAC PULSE GENERATOR | Nov 29, 1979 | Substantially Equivalent |
| K792299 | ARCOLITH 3020-CARDIAC PULSE GENERATOR | Nov 29, 1979 | Substantially Equivalent |
| K791715 | ARCOLITH 2000 | Sep 27, 1979 | Substantially Equivalent |
| K791147 | ARCO PROGAMMABLE PACEMAKER SYSTEM | Aug 3, 1979 | Substantially Equivalent |