FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
CORATOMIC MODEL OVALITH-920
K Number: K810808
·
Decision May 15, 1981
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
15
Review Days
52
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Basic Information
- Device Name
- CORATOMIC MODEL OVALITH-920
- K Number
- K810808
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Coratomic, Inc.
- Date Received
- March 24, 1981
- Decision Date
- May 15, 1981
- 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
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OPUS S MODEL 4121 AND 4124 PACEMAKERS
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FDA Class 3
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PIKOS LP 01, PIKOS LP E01
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FDA Class 3
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ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
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FDA Class 3
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MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Coratomic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863365 | MODIFICATION OF STERILITY CYCLE PARAMETERS | Oct 8, 1986 | Substantially Equivalent |
| K822791 | CORATOMIC #VX5-105 & VX5-205 PULSE GEN. | Dec 15, 1982 | Substantially Equivalent |
| K820939 | C-101-P | Jun 22, 1982 | Substantially Equivalent |
| K821014 | CORATOMIC MODEL OVALITH 920BP | May 28, 1982 | Substantially Equivalent |
| K821033 | CORATOMIC MODEL OVALITH-920 | May 28, 1982 | Substantially Equivalent |
| K802689 | L-15T ENDOCARDIAL PACING ELECTRODE | Oct 28, 1980 | Unknown |
| K800194 | OVALITH P-BP BIPOLAR CARDIAC PACEMAKER | Feb 11, 1980 | Substantially Equivalent |
| K790446 | OVALITH-300 | Jul 30, 1979 | Substantially Equivalent |
| K781377 | OVALITH 10BP | Dec 4, 1978 | Substantially Equivalent |
| K780569 | L-12, L-21, AND L-22 ELECTRODES | Jun 14, 1978 | Substantially Equivalent |