FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
IMPLANTABLE VENTRICULAR-INHIBITED
K Number: K791727
·
Decision Sep 27, 1979
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
107
Review Days
27
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Basic Information
- Device Name
- IMPLANTABLE VENTRICULAR-INHIBITED
- K Number
- K791727
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Telectronics, Inc.
- Date Received
- August 31, 1979
- Decision Date
- September 27, 1979
- 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 Telectronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890895 | IMPLANTABLE ADAPTOR 033-380 | Mar 6, 1990 | Substantially Equivalent |
| K891231 | OPTIMA MPT AND SPT PACEMAKERS | Sep 12, 1989 | Substantially Equivalent |
| K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) | Feb 2, 1989 | Substantially Equivalent |
| K884411 | OPTIMA MPT AND SPT PACEMAKERS | Jan 26, 1989 | Substantially Equivalent |
| K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 | Dec 15, 1988 | Substantially Equivalent |
| K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D | Jul 18, 1988 | Substantially Equivalent |
| K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 | May 31, 1988 | Substantially Equivalent |
| K864712 | MODEL 1740 PERSONAL POCKET PROGRAMMER | Dec 17, 1987 | Substantially Equivalent |
| K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | Nov 4, 1987 | Substantially Equivalent |
| K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 | Aug 18, 1987 | Substantially Equivalent |