FDA Product Code
FDA Product Code DXY — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3610
510(k) Clearances — 461 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993434 | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | Biotronik, Inc. | 1999-11-10 | Special | PDF ↗ |
| K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS | Ela Medical, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K945627 | PIKOS LP 01, PIKOS LP E01 | Biotronik, Inc. | 1996-03-04 | Traditional | PDF ↗ |
| K954092 | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | Medtronic Vascular | 1995-12-15 | Traditional | PDF ↗ |
| K953866 | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | Medtronic Vascular | 1995-12-15 | Traditional | PDF ↗ |
| K952328 | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 | Biotronik, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | Cook Pacemaker Corp. | 1995-09-29 | Traditional | PDF ↗ |
| K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | Ela Medical, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K940039 | PELLETHANE 75D | Medtronic Vascular | 1995-07-12 | Traditional | PDF ↗ |
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | Cardiac Control Systems, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K950751 | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | Medtronic Vascular | 1995-05-15 | Traditional | PDF ↗ |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | Cardiac Control Systems, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K941937 | PIKOS E 01-B | Biotronik, Inc. | 1994-08-30 | Traditional | PDF ↗ |
| K932884 | MINIX/MINIX ST PULSE GENERATORS | Medtronic Vascular | 1994-05-02 | Traditional | PDF ↗ |
| K923026 | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | Biotronik, GmbH & Co. | 1993-08-19 | Traditional | PDF ↗ |
| K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | Cardiac Control Systems, Inc. | 1993-05-14 | Traditional | PDF ↗ |
| K930770 | MEDTRONIC MINIX & MINIX ST PULSE GENERATORS | Medtronic Vascular | 1993-05-14 | Traditional | PDF ↗ |
| K920601 | ASTRA T2, ASTRA T4, ASTRA T6 | Cardiac Pacemakers, Inc. | 1992-10-28 | Traditional | PDF ↗ |
| K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | Intermedics, Inc. | 1992-03-17 | Traditional | PDF ↗ |
| K920157 | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER | Schneider Intl., Ltd. | 1992-03-16 | Traditional | PDF ↗ |
| K914109 | PIKOS 01 & PIKOS E 01 | Biotronik, GmbH & Co. | 1992-02-26 | Traditional | PDF ↗ |
| K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER | Cook Pacemaker Corp. | 1991-10-16 | Traditional | PDF ↗ |
| K913134 | MODEL 4220 | Pace Medical | 1991-08-22 | Traditional | PDF ↗ |
| K912545 | MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE | Pace Medical | 1991-07-26 | Traditional | PDF ↗ |
| K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | Cardiac Control Systems, Inc. | 1991-05-16 | Traditional | PDF ↗ |
| K911122 | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS | Intermedics, Inc. | 1991-05-16 | Traditional | PDF ↗ |
| K905087 | TRIOS 02 | Biotronik, GmbH & Co. | 1991-05-07 | Traditional | PDF ↗ |
| K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | Telectronics Pacing Systems, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K904602 | MEDTRONIC MODEL 5301B TEST CABLE | Medtronic Vascular | 1991-01-03 | Traditional | PDF ↗ |
| K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | Cardiac Control Systems, Inc. | 1991-01-03 | Traditional | PDF ↗ |
| K904892 | VACUUM BAKE CYCLE | Medtronic Vascular | 1990-12-20 | Traditional | PDF ↗ |
| K903919 | IMPLANTABLE PULSE DEVICES | Medtronic Vascular | 1990-10-23 | Traditional | PDF ↗ |
| K903081 | NEOS (TM) 02 B PULSE GENERATOR | Biotronik, GmbH & Co. | 1990-09-14 | Traditional | PDF ↗ |
| K901535 | MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. | Medtronic Vascular | 1990-07-03 | Traditional | PDF ↗ |
| K902134 | MINIX, MINIX ST, NEW IC: L74 | Medtronic Vascular | 1990-07-03 | Traditional | PDF ↗ |
| K900622 | MODIFIED MODEL 5401B TEST CABLE | Medtronic Vascular | 1990-04-26 | Traditional | PDF ↗ |
| K900461 | OPUS MODEL 4021, VVI, 5MM UNIPOLAR | Ela Medical, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K897116 | OPTIMA MPT MODEL 5281E AND MODEL 5282E | Telectronics Pacing Systems, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K896809 | MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR | Medtronic Vascular | 1990-01-26 | Traditional | PDF ↗ |
| K896184 | KALOS 05 PULSE GENERATOR | Biotronik Cardiac Pacemakers | 1990-01-18 | Traditional | PDF ↗ |
| K894239 | NANOS | Biotronik Cardiac Pacemakers | 1989-11-01 | Traditional | PDF ↗ |
| K894240 | NEOS 02 | Biotronik Cardiac Pacemakers | 1989-10-26 | Traditional | PDF ↗ |
| K894494 | LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD | Biotronik, GmbH & Co. | 1989-10-17 | Traditional | PDF ↗ |
| K894065 | OPUS MODEL 4001 | Ela Medical, Inc. | 1989-09-26 | Traditional | PDF ↗ |
| K895495 | ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS | Medtronic Vascular | 1989-09-26 | Traditional | PDF ↗ |
| K894267 | OPUS MODELS 4033 AND 4034 | Ela Medical, Inc. | 1989-09-20 | Traditional | PDF ↗ |
| K891231 | OPTIMA MPT AND SPT PACEMAKERS | Telectronics, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K894055 | MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS | Medtronic Vascular | 1989-08-25 | Traditional | PDF ↗ |
| K884420 | HOME BLOOD PRESSURE KIT, ANEROID | Yamasu Co. , Ltd. | 1989-08-25 | Traditional | PDF ↗ |
| K894185 | OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR | Telectronics Pacing Systems, Inc. | 1989-08-17 | Traditional | PDF ↗ |
| K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR | Pacesetter Systems | 1989-03-28 | Traditional | PDF ↗ |
| K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE | Cardiac Pacemakers, Inc. | 1989-03-10 | Traditional | PDF ↗ |
| K884733 | AFP MODEL 262T PULSE GENERATOR | Pacesetter Systems | 1989-02-10 | Traditional | PDF ↗ |
| K884411 | OPTIMA MPT AND SPT PACEMAKERS | Telectronics, Inc. | 1989-01-26 | Traditional | PDF ↗ |
| K883037 | UNILITH 3 MODELS 7580/7583/7680/7683 | Ela Medical, Inc. | 1989-01-25 | Traditional | PDF ↗ |
| K883750 | VENTRALITH I | Bio Pace Technology, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K884215 | MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331 | Medtronic Vascular | 1988-11-17 | Traditional | PDF ↗ |
| K883755 | MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS | Medtronic Vascular | 1988-11-17 | Traditional | PDF ↗ |
| K882391 | OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 | Ela Medical, Inc. | 1988-11-14 | Traditional | PDF ↗ |
| K884023 | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER | Cardiac Control Systems, Inc. | 1988-10-17 | Traditional | PDF ↗ |
| K882427 | CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 | Ela Medical, Inc. | 1988-09-23 | Traditional | PDF ↗ |
| K883087 | PROLOG MP 658M PULSE GENERATOR | Pacesetter Systems | 1988-09-14 | Traditional | PDF ↗ |
| K882474 | OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 | Ela Medical, Inc. | 1988-09-12 | Traditional | PDF ↗ |
| K882476 | OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 | Ela Medical, Inc. | 1988-09-12 | Traditional | PDF ↗ |
| K881904 | CHANGE TO CATHODE POWDER SPECIFICATION | Telectronics and Cordis Pacing Systems | 1988-07-22 | Traditional | PDF ↗ |
| K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D | Telectronics, Inc. | 1988-07-18 | Traditional | PDF ↗ |
| K881711 | VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. | Telectronics and Cordis Pacing Systems | 1988-05-26 | Traditional | PDF ↗ |
| K880898 | MULTICOR AND PACEMAKERS | Tpl-Cordis, Inc. | 1988-05-06 | Traditional | PDF ↗ |
| K880326 | MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS | Cardiac Control Systems, Inc. | 1988-04-11 | Traditional | PDF ↗ |
| K880422 | MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER | Cardiac Control Systems, Inc. | 1988-03-31 | Traditional | PDF ↗ |
| K880432 | VICOR PACER, MODEL 410A | Tpl-Cordis, Inc. | 1988-02-22 | Traditional | PDF ↗ |
| K873158 | MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS | Tpl-Cordis, Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K874158 | CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. | Cardiac Control Systems, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K874394 | QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. | Intermedics, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | Telectronics, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K872779 | PROLOG MP PULSE GENERATORS 658K AND 658T | Pacesetter Systems | 1987-11-04 | Traditional | PDF ↗ |
| K873202 | VICOR, MODEL 410A | Tpl-Cordis, Inc. | 1987-10-15 | Traditional | PDF ↗ |
| K873528 | MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS | Intermedics, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K871992 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | Telectronics, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K871866 | MEDTRONIC CLASSIX MODELS 8436/8437/8438 | Medtronic Vascular | 1987-08-10 | Traditional | PDF ↗ |
| K871861 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | Telectronics, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K870142 | PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR | Cardio-Pace Medical, Inc. | 1987-04-22 | Traditional | PDF ↗ |
| K865013 | ASTRA T2, T4 AND T6 | Cardiac Pacemakers, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K863898 | MULTILITH 3 MODELS 1350, 3350, 1370, 3370 | Ela Medical, Inc. | 1987-02-10 | Traditional | PDF ↗ |
| K862226 | DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS | Pacesetter Systems | 1987-02-03 | Traditional | PDF ↗ |
| K860036 | EDP-20 PACEMAKER | Biotronik Sales, Inc. | 1987-01-12 | Traditional | PDF ↗ |
| K862459 | MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE | Medtronic Vascular | 1987-01-02 | Traditional | PDF ↗ |
| K863878 | TRIOS-M VS-1 PULSE GENERATOR | Biotronik Sales, Inc. | 1986-12-10 | Traditional | PDF ↗ |
| K863879 | NEOS-M VS-1 PULSE GENERATOR | Biotronik Sales, Inc. | 1986-12-10 | Traditional | PDF ↗ |
| K863582 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) | Cook Pacemaker Corp. | 1986-10-08 | Traditional | PDF ↗ |
| K863365 | MODIFICATION OF STERILITY CYCLE PARAMETERS | Coratomic, Inc. | 1986-10-08 | Traditional | PDF ↗ |
| K863417 | CORDIS MULTICOR II MODEL 402D PACER | Cordis Corp. | 1986-10-08 | Traditional | PDF ↗ |
| K863418 | MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE | Intermedics, Inc. | 1986-09-24 | Traditional | PDF ↗ |
| K862974 | ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. | Medtronic Vascular | 1986-09-04 | Traditional | PDF ↗ |
| K854790 | CERYX PACEMAKER MODELS 114, 314 & 614 | Vitatron Medical BV | 1986-08-28 | Traditional | PDF ↗ |
| K860921 | NEOS VS-1, PULSE GENERATOR | Biotronik Sales, Inc. | 1986-08-08 | Traditional | PDF ↗ |
| K860922 | MIKROS, MIKROS VS-1, PULSE GENERATOR | Biotronik Sales, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K860585 | ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR | Cardiac Pacemakers, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K853771 | PINNACLE MULTI-PROGRAMMABLE PACING SYS | Cardio-Pace Medical, Inc. | 1986-07-15 | Traditional | PDF ↗ |
| K861719 | MODIFIED MODELS 8320/8322/8329/8316/8317/8318 | Medtronic Vascular | 1986-07-01 | Traditional | PDF ↗ |
Product code DXY · Class III · Cardiovascular. Data: openFDA.