510(k) K871992
- Device
- IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- Applicant
- TELECTRONICS, INC.
- 510(k) number
- K871992
- Product code
- DXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-12
- Date received
- 1987-05-26
- Regulation
- 870.3610
- Classification name
- Implantable Pacemaker Pulse-generator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM C NEALON
- Address
- 40 Crane Hill Rd. Suffield CT US 06078 06078
FDA Registration Numbers#
- 3006705815
- 1028232
- 3003120897
- 2648729
- 3004209178
- 2024024
- 2649622
- 2135338
- 3013288201
- 3008159616
- 9614453
- 3008494315
- 2017865
- 2124215
- 3002806603
- 3012552532
- 3008483389
- 3009380063
- 2032521
- 3018094310
- 9610139
- 1000165971
- 3008973940
- 3004593495
- 3005334138
- 2182208
- 2133641
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993434 | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | Biotronik, Inc. | 1999-11-10 |
| K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS | Ela Medical, Inc. | 1997-08-29 |
| K945627 | PIKOS LP 01, PIKOS LP E01 | Biotronik, Inc. | 1996-03-04 |
| K954092 | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | Medtronic Vascular | 1995-12-15 |
| K953866 | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | Medtronic Vascular | 1995-12-15 |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | Cook Pacemaker Corp. | 1995-09-29 |
| K952328 | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 | Biotronik, Inc. | 1995-09-29 |
| K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | Ela Medical, Inc. | 1995-09-01 |
| K940039 | PELLETHANE 75D | Medtronic Vascular | 1995-07-12 |
| K950751 | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | Medtronic Vascular | 1995-05-15 |
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | Cardiac Control Systems, Inc. | 1995-05-15 |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | Cardiac Control Systems, Inc. | 1995-05-03 |
| K941937 | PIKOS E 01-B | Biotronik, Inc. | 1994-08-30 |
| K932884 | MINIX/MINIX ST PULSE GENERATORS | Medtronic Vascular | 1994-05-02 |
| K923026 | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | Biotronik, GmbH & Co. | 1993-08-19 |
Legacy Summary#
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FDA Review#
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