DXY — Implantable Pacemaker Pulse-Generator Class III
FDA product code DXY covers "Implantable Pacemaker Pulse-Generator", a Class III medical device regulated under 21 CFR 870.3610. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K950751 | medtronic vascular | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | May 15, 1995 |
| K946188 | cardiac control systems | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | 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 |
| K923868 | cardiac control systems | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | May 14, 1993 |
| K930770 | medtronic vascular | MEDTRONIC MINIX & MINIX ST PULSE GENERATORS | 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 |