FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACEMAKER ELECTRODE INSERTER AIDE
K Number: K800088
·
Decision Jan 29, 1980
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
107
Review Days
15
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Basic Information
- Device Name
- PACEMAKER ELECTRODE INSERTER AIDE
- K Number
- K800088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Telectronics, Inc.
- Date Received
- January 14, 1980
- Decision Date
- January 29, 1980
- Product Code
- DTE
- 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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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 |