DXY — Implantable Pacemaker Pulse-Generator Class III
FDA Device Classification
Classification Details
- Product Code
- DXY
- Device Class
- Class III
- Regulation Number
- 870.3610
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K993434 | biotronik | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | November 10, 1999 |
| K970072 | ela medical | OPUS S MODEL 4121 AND 4124 PACEMAKERS | August 29, 1997 |
| K945627 | biotronik | PIKOS LP 01, PIKOS LP E01 | March 4, 1996 |
| K953866 | medtronic vascular | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | December 15, 1995 |
| K954092 | medtronic vascular | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | December 15, 1995 |
| K952328 | biotronik | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 | September 29, 1995 |
| K953417 | cook pacemaker | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | September 29, 1995 |
| K952364 | ela medical | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | September 1, 1995 |
| K940039 | medtronic vascular | PELLETHANE 75D | July 12, 1995 |
| K946188 | cardiac control systems | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | May 15, 1995 |
| K950751 | medtronic vascular | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | May 15, 1995 |
| K950210 | cardiac control systems | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | May 3, 1995 |
| K941937 | biotronik | PIKOS E 01-B | August 30, 1994 |
| K932884 | medtronic vascular | MINIX/MINIX ST PULSE GENERATORS | May 2, 1994 |
| K923026 | biotronik, gmbh and | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | August 19, 1993 |
| K930770 | medtronic vascular | MEDTRONIC MINIX & MINIX ST PULSE GENERATORS | May 14, 1993 |
| K923868 | cardiac control systems | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | May 14, 1993 |
| K920601 | cardiac pacemakers | ASTRA T2, ASTRA T4, ASTRA T6 | October 28, 1992 |
| K920530 | intermedics | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | March 17, 1992 |
| K920157 | schneider intl | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER | March 16, 1992 |