FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PULSE GENERATOR
K Number: K821073
·
Decision May 7, 1982
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
41
Review Days
21
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Basic Information
- Device Name
- PULSE GENERATOR
- K Number
- K821073
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Biotronik Sales, Inc.
- Date Received
- April 16, 1982
- Decision Date
- May 7, 1982
- 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
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Biotronik Sales, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K875199 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR | Feb 18, 1988 | Substantially Equivalent |
| K853194 | ERA-20 | Mar 11, 1987 | Substantially Equivalent |
| K860036 | EDP-20 PACEMAKER | Jan 12, 1987 | Substantially Equivalent |
| K863879 | NEOS-M VS-1 PULSE GENERATOR | Dec 10, 1986 | Substantially Equivalent |
| K863878 | TRIOS-M VS-1 PULSE GENERATOR | Dec 10, 1986 | Substantially Equivalent |
| K863480 | BIOTRONIK PERMANENT PACEMAKER ELECTRODE | Sep 23, 1986 | Substantially Equivalent |
| K860921 | NEOS VS-1, PULSE GENERATOR | Aug 8, 1986 | Substantially Equivalent |
| K860922 | MIKROS, MIKROS VS-1, PULSE GENERATOR | Aug 4, 1986 | Substantially Equivalent |
| K853567 | DJP UNIPOLAR | May 7, 1986 | Substantially Equivalent |
| K853566 | DJ UNIPOLAR | May 7, 1986 | Substantially Equivalent |