The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Cpi Lead Adapters, Models 6017, 6018 And 6020.
| Device ID | K041574 |
| 510k Number | K041574 |
| Device Name: | CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 |
| Classification | Pacemaker Lead Adaptor |
| Applicant | GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5798 |
| Contact | Amita Shenai |
| Correspondent | Amita Shenai GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5798 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-07-12 |