Telectronics, Inc.
Mchenry, IL, US
Telectronics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 107 510(k) clearances between and , 6 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 107
- PMA records
- 6
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 107FDA records hold 107 510(k) clearances for Telectronics, Inc. between 1977 and 1990. The busiest year on record is 1985, with 21. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 14 |
| 1979 | 14 |
| 1980 | 11 |
| 1981 | 11 |
| 1982 | 1 |
| 1983 | 5 |
| 1984 | 8 |
| 1985 | 21 |
| 1986 | 5 |
| 1987 | 8 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K890895 | IMPLANTABLE ADAPTOR 033-380 | DTD | Substantially Equivalent | |
| K891231 | OPTIMA MPT AND SPT PACEMAKERS | DXY | Substantially Equivalent | |
| K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) | DTB | Substantially Equivalent | |
| K884411 | OPTIMA MPT AND SPT PACEMAKERS | DXY | Substantially Equivalent | |
| K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 | DTB | Substantially Equivalent | |
| K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D | DXY | Substantially Equivalent | |
| K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 | DTB | Substantially Equivalent | |
| K864712 | MODEL 1740 PERSONAL POCKET PROGRAMMER | KRG | Substantially Equivalent | |
| K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | DXY | Substantially Equivalent | |
| K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 | DTB | Substantially Equivalent | |
| K871992 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | DXY | Substantially Equivalent | |
| K871986 | MODEL 5600B PROGRAMMER, PACEMAKER | KRG | Substantially Equivalent | |
| K871861 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | DXY | Substantially Equivalent | |
| K864618 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 | DTB | Substantially Equivalent | |
| K870610 | RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE | DTB | Substantially Equivalent | |
| K861767 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-436 | DTB | Substantially Equivalent | |
| K860573 | IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR | DXY | Substantially Equivalent | |
| K854997 | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY | DTD | Substantially Equivalent | |
| K854560 | IMPLANTABLE PROGRAMMABLE PULSE GENERATOR | DXY | Substantially Equivalent | |
| K854142 | STYLET INTRODUCER FUNNEL | DTB | Substantially Equivalent | |
| K852710 | IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A | DTB | Substantially Equivalent | |
| K854143 | BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS | DXY | Substantially Equivalent | |
| K852708 | IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A | DTB | Substantially Equivalent | |
| K853223 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407 | DTB | Substantially Equivalent | |
| K853222 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402 | DTB | Substantially Equivalent | |
| K853221 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 | DTB | Substantially Equivalent | |
| K852709 | IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A | DTB | Substantially Equivalent | |
| K852972 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-400 | DTB | Substantially Equivalent | |
| K853206 | IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW | DXY | Substantially Equivalent | |
| K852918 | SLIM ART J. BIP PACING LEAD USING POLY #030-2821 | DYB | Substantially Equivalent | |
| K852917 | SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283 | DYB | Substantially Equivalent | |
| K852916 | SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 | DYB | Substantially Equivalent | |
| K852915 | SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 | DTB | Substantially Equivalent | |
| K851461 | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE | DTB | Substantially Equivalent | |
| K851460 | NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA | BXY | Substantially Equivalent | |
| K851296 | IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH | DTB | Substantially Equivalent | |
| K851297 | IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET | DTB | Substantially Equivalent | |
| K851295 | IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH | DTB | Substantially Equivalent | |
| K851294 | IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH | DTB | Substantially Equivalent | |
| K851081 | IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II | DXY | Substantially Equivalent | |
| K850252 | QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR | DXY | Substantially Equivalent | |
| K842473 | IMPLANTABLE PROGRAMMABLE PULSE GENERAT | DXY | Substantially Equivalent | |
| K840026 | IMPLANTABLE ELECTRODE UNIPOLAR ADAPT | DTD | Substantially Equivalent | |
| K840025 | IMPLANTABLE ELECTRODE BIPOLAR ADAPT | DTD | Substantially Equivalent | |
| K840737 | IMPLANTABLE PROGRAMMABLE PULSE GENER | DXY | Substantially Equivalent | |
| K840701 | PACEMAKER 147 VVI-THE OPTINIA | DXY | Substantially Equivalent | |
| K833428 | IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN | DXY | Substantially Equivalent | |
| K833427 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN | DXY | Substantially Equivalent | |
| K834533 | ELECTRODE LEAD CONSTRUCTION | DTB | Substantially Equivalent | |
| K833798 | OPTIMA MDT PULSE GENERATOR W/TELEMETRY | DXY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTCAnalyzer, Pacemaker Generator Function
- DSKComputer, Blood-Pressure
- BXYFlowmeter, Calibration, Gas
- DXYImplantable Pacemaker Pulse-Generator
- DYBIntroducer, Catheter
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DTDPacemaker Lead Adaptor
- DTBPermanent Pacemaker Electrode
- KRGProgrammer, Pacemaker
- DTEPulse-Generator, Pacemaker, External
- LWWPulse-Generator, Single Chamber, Single
- DSFRecorder, Paper Chart
- DTFTools, Pacemaker Service
- DRSTransducer, Blood-Pressure, Extravascular
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain