Company ยท US
Telectronics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1990. Name variants (Inc, Corp, punctuation) are merged.
107510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 47 |
| DTB | Permanent Pacemaker Electrode | 35 |
| DTD | Pacemaker Lead Adaptor | 8 |
| DTE | Pulse-Generator, Pacemaker, External | 3 |
| DYB | Introducer, Catheter | 3 |
| KRG | Programmer, Pacemaker | 2 |
| BXY | Flowmeter, Calibration, Gas | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DSF | Recorder, Paper Chart | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DTC | Analyzer, Pacemaker Generator Function | 1 |
| DTF | Tools, Pacemaker Service | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 1990 | K890895 | IMPLANTABLE ADAPTOR 033-380 Telectronics, Inc. | DTD |
| Sep 12, 1989 | K891231 | OPTIMA MPT AND SPT PACEMAKERS Telectronics, Inc. | DXY |
| Feb 2, 1989 | K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) Telectronics, Inc. | DTB |
| Jan 26, 1989 | K884411 | OPTIMA MPT AND SPT PACEMAKERS Telectronics, Inc. | DXY |
| Dec 15, 1988 | K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 Telectronics, Inc. | DTB |
| Jul 18, 1988 | K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D Telectronics, Inc. | DXY |
| May 31, 1988 | K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 Telectronics, Inc. | DTB |
| Dec 17, 1987 | K864712 | MODEL 1740 PERSONAL POCKET PROGRAMMER Telectronics, Inc. | KRG |
| Nov 4, 1987 | K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. | DXY |
| Aug 18, 1987 | K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 Telectronics, Inc. | DTB |
| Aug 12, 1987 | K871992 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. | DXY |
| Jun 24, 1987 | K871986 | MODEL 5600B PROGRAMMER, PACEMAKER Telectronics, Inc. | KRG |
| Jun 5, 1987 | K871861 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. | DXY |
| May 21, 1987 | K864618 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 Telectronics, Inc. | DTB |
| Mar 20, 1987 | K870610 | RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE Telectronics, Inc. | DTB |
| Jul 18, 1986 | K861767 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-436 Telectronics, Inc. | DTB |
| May 28, 1986 | K860573 | IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR Telectronics, Inc. | DXY |
| Feb 12, 1986 | K854997 | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY Telectronics, Inc. | DTD |
| Jan 16, 1986 | K854560 | IMPLANTABLE PROGRAMMABLE PULSE GENERATOR Telectronics, Inc. | DXY |
| Jan 15, 1986 | K854142 | STYLET INTRODUCER FUNNEL Telectronics, Inc. | DTB |
| Dec 4, 1985 | K852710 | IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A Telectronics, Inc. | DTB |
| Nov 1, 1985 | K854143 | BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS Telectronics, Inc. | DXY |
| Oct 1, 1985 | K852708 | IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A Telectronics, Inc. | DTB |
| Sep 17, 1985 | K853223 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407 Telectronics, Inc. | DTB |
| Sep 17, 1985 | K853222 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402 Telectronics, Inc. | DTB |
| Sep 17, 1985 | K853221 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 Telectronics, Inc. | DTB |
| Sep 17, 1985 | K852709 | IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A Telectronics, Inc. | DTB |
| Sep 16, 1985 | K852972 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-400 Telectronics, Inc. | DTB |
| Sep 12, 1985 | K853206 | IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW Telectronics, Inc. | DXY |
| Jul 29, 1985 | K852918 | SLIM ART J. BIP PACING LEAD USING POLY #030-2821 Telectronics, Inc. | DYB |
| Jul 29, 1985 | K852917 | SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283 Telectronics, Inc. | DYB |
| Jul 29, 1985 | K852916 | SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 Telectronics, Inc. | DYB |
| Jul 29, 1985 | K852915 | SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 Telectronics, Inc. | DTB |
| Jul 11, 1985 | K851461 | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE Telectronics, Inc. | DTB |
| May 10, 1985 | K851460 | NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA Telectronics, Inc. | BXY |
| Apr 11, 1985 | K851296 | IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH Telectronics, Inc. | DTB |
| Apr 10, 1985 | K851297 | IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET Telectronics, Inc. | DTB |
| Apr 10, 1985 | K851295 | IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH Telectronics, Inc. | DTB |
| Apr 10, 1985 | K851294 | IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH Telectronics, Inc. | DTB |
| Apr 4, 1985 | K851081 | IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II Telectronics, Inc. | DXY |
| Apr 4, 1985 | K850252 | QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR Telectronics, Inc. | DXY |
| Oct 26, 1984 | K842473 | IMPLANTABLE PROGRAMMABLE PULSE GENERAT Telectronics, Inc. | DXY |
| May 23, 1984 | K840026 | IMPLANTABLE ELECTRODE UNIPOLAR ADAPT Telectronics, Inc. | DTD |
| May 23, 1984 | K840025 | IMPLANTABLE ELECTRODE BIPOLAR ADAPT Telectronics, Inc. | DTD |
| May 16, 1984 | K840737 | IMPLANTABLE PROGRAMMABLE PULSE GENER Telectronics, Inc. | DXY |
| May 2, 1984 | K840701 | PACEMAKER 147 VVI-THE OPTINIA Telectronics, Inc. | DXY |
| Feb 10, 1984 | K833428 | IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN Telectronics, Inc. | DXY |
| Feb 10, 1984 | K833427 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN Telectronics, Inc. | DXY |
| Jan 30, 1984 | K834533 | ELECTRODE LEAD CONSTRUCTION Telectronics, Inc. | DTB |
| Dec 1, 1983 | K833798 | OPTIMA MDT PULSE GENERATOR W/TELEMETRY Telectronics, Inc. | DXY |
Newest 50 of 107.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||