510(k) K041574
- Device
- CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
- Applicant
- GUIDANT CORPORATION
- 510(k) number
- K041574
- Product code
- DTD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-07-12
- Date received
- 2004-06-14
- Regulation
- 870.3620
- Classification name
- Pacemaker Lead Adaptor
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- AMITA SHENAI
- Address
- 4100 Hamline Ave. N St Paul MN US 55112 55112
FDA Registration Numbers#
- 2017865
- 2183787
- 3004785273
- 2030624
- 2124215
- 9610139
- 3005029049
- 1035166
- 2183744
- 1028232
- 2182208
- 2649622
- 1061927
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DTD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143463 | IS4/DF4 Port Plug | Oscor, Inc. | 2015-03-19 |
| K132008 | 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP | Medtronic, Inc. | 2013-07-30 |
| K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | Oscor, Inc. | 2003-06-19 |
| K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | Oscor, Inc. | 2003-01-14 |
| K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | Oscor, Inc. | 2001-05-22 |
| K003454 | A1-CS-SB Y-ADAPTER, MODEL 124 871 | Biotronik, Inc. | 2001-01-18 |
| K000210 | MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT | Medtronic Vascular | 2000-02-23 |
| K982220 | MODEL 2872 BIPOLAR LEAD ADAPTOR KIT | Medtronic Vascular | 1998-10-15 |
| K971930 | BK-N SEALING CAP | Biotronik, Inc. | 1997-08-14 |
| K970388 | A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE | Biotronik, Inc. | 1997-08-14 |
| K970204 | BK-A; BK-B; BK-IS SEALING CAP | Biotronik, Inc. | 1997-04-29 |
| K950140 | IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 | Pacesetter, Inc. | 1995-04-06 |
| K934899 | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | Telectronics Pacing Systems, Inc. | 1994-05-12 |
| K925168 | MISCELLANEOUS PACING LEAD | Oscor Medical Corp. | 1994-05-03 |
| K921318 | ADAPTING SLEEVE KIT MODEL 4023 | Siemens-Pacesetter, Inc. | 1992-08-03 |
Legacy Summary#
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FDA Review#
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