Panels › Cardiovascular › Product code DXY · Class 3
Implantable Pacemaker Pulse-Generator
Regulation 870.3610
0510(k)s in 12 months (461 all time)
0recalls in 12 months (75 all time)
1recalls that name a 510(k)
Top companies in DXY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 59 | 0 |
| Intermedics, Inc. | 52 | 0 |
| Telectronics, Inc. | 47 | 0 |
| Cardiac Pacemakers, Inc. | 37 | 0 |
| Guidant Corp-Cpi Division | 0 | 32 |
| Pacesetter Systems | 28 | 0 |
| Cook Pacemaker Corp. | 24 | 0 |
| Ela Medical, Inc. | 22 | 2 |
| Biotronik Sales, Inc. | 22 | 0 |
| Cordis Corp. | 21 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 10, 1999 | K993434 | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A Biotronik, Inc. | DXY |
| Aug 29, 1997 | K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS Ela Medical, Inc. | DXY |
| Mar 4, 1996 | K945627 | PIKOS LP 01, PIKOS LP E01 Biotronik, Inc. | DXY |
| Dec 15, 1995 | K954092 | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) Medtronic Vascular | DXY |
| Dec 15, 1995 | K953866 | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) Medtronic Vascular | DXY |
| Sep 29, 1995 | K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS Cook Pacemaker Corp. | DXY |
| Sep 29, 1995 | K952328 | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 Biotronik, Inc. | DXY |
| Sep 1, 1995 | K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) Ela Medical, Inc. | DXY |
| Jul 12, 1995 | K940039 | PELLETHANE 75D Medtronic Vascular | DXY |
| May 15, 1995 | K950751 | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES Medtronic Vascular | DXY |
| May 15, 1995 | K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER Cardiac Control Systems, Inc. | DXY |
| May 3, 1995 | K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER Cardiac Control Systems, Inc. | DXY |
| Aug 30, 1994 | K941937 | PIKOS E 01-B Biotronik, Inc. | DXY |
| May 2, 1994 | K932884 | MINIX/MINIX ST PULSE GENERATORS Medtronic Vascular | DXY |
| Aug 19, 1993 | K923026 | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER Biotronik, GmbH & Co. | DXY |
| May 14, 1993 | K930770 | MEDTRONIC MINIX & MINIX ST PULSE GENERATORS Medtronic Vascular | DXY |
| May 14, 1993 | K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER Cardiac Control Systems, Inc. | DXY |
| Oct 28, 1992 | K920601 | ASTRA T2, ASTRA T4, ASTRA T6 Cardiac Pacemakers, Inc. | DXY |
| Mar 17, 1992 | K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG Intermedics, Inc. | DXY |
| Mar 16, 1992 | K920157 | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER Schneider Intl., Ltd. | DXY |
| Feb 26, 1992 | K914109 | PIKOS 01 & PIKOS E 01 Biotronik, GmbH & Co. | DXY |
| Oct 16, 1991 | K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER Cook Pacemaker Corp. | DXY |
| Aug 22, 1991 | K913134 | MODEL 4220 Pace Medical | DXY |
| Jul 26, 1991 | K912545 | MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE Pace Medical | DXY |
| May 16, 1991 | K911122 | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS Intermedics, Inc. | DXY |
| May 16, 1991 | K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE Cardiac Control Systems, Inc. | DXY |
| May 7, 1991 | K905087 | TRIOS 02 Biotronik, GmbH & Co. | DXY |
| Jan 18, 1991 | K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE Telectronics Pacing Systems, Inc. | DXY |
| Jan 3, 1991 | K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE Cardiac Control Systems, Inc. | DXY |
| Jan 3, 1991 | K904602 | MEDTRONIC MODEL 5301B TEST CABLE Medtronic Vascular | DXY |
| Dec 20, 1990 | K904892 | VACUUM BAKE CYCLE Medtronic Vascular | DXY |
| Oct 23, 1990 | K903919 | IMPLANTABLE PULSE DEVICES Medtronic Vascular | DXY |
| Sep 14, 1990 | K903081 | NEOS (TM) 02 B PULSE GENERATOR Biotronik, GmbH & Co. | DXY |
| Jul 3, 1990 | K902134 | MINIX, MINIX ST, NEW IC: L74 Medtronic Vascular | DXY |
| Jul 3, 1990 | K901535 | MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. Medtronic Vascular | DXY |
| Apr 26, 1990 | K900622 | MODIFIED MODEL 5401B TEST CABLE Medtronic Vascular | DXY |
| Mar 14, 1990 | K900461 | OPUS MODEL 4021, VVI, 5MM UNIPOLAR Ela Medical, Inc. | DXY |
| Mar 14, 1990 | K897116 | OPTIMA MPT MODEL 5281E AND MODEL 5282E Telectronics Pacing Systems, Inc. | DXY |
| Jan 26, 1990 | K896809 | MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR Medtronic Vascular | DXY |
| Jan 18, 1990 | K896184 | KALOS 05 PULSE GENERATOR Biotronik Cardiac Pacemakers | DXY |
| Nov 1, 1989 | K894239 | NANOS Biotronik Cardiac Pacemakers | DXY |
| Oct 26, 1989 | K894240 | NEOS 02 Biotronik Cardiac Pacemakers | DXY |
| Oct 17, 1989 | K894494 | LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD Biotronik, GmbH & Co. | DXY |
| Sep 26, 1989 | K895495 | ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS Medtronic Vascular | DXY |
| Sep 26, 1989 | K894065 | OPUS MODEL 4001 Ela Medical, Inc. | DXY |
| Sep 20, 1989 | K894267 | OPUS MODELS 4033 AND 4034 Ela Medical, Inc. | DXY |
| Sep 12, 1989 | K891231 | OPTIMA MPT AND SPT PACEMAKERS Telectronics, Inc. | DXY |
| Aug 25, 1989 | K894055 | MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS Medtronic Vascular | DXY |
| Aug 25, 1989 | K884420 | HOME BLOOD PRESSURE KIT, ANEROID Yamasu Co. , Ltd., JP | DXY |
| Aug 17, 1989 | K894185 | OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR Telectronics Pacing Systems, Inc. | DXY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.