The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Flex 10 Mis Ablation Probe, Model Flx10mi-05.
| Device ID | K061865 |
| 510k Number | K061865 |
| Device Name: | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Christina L Lowe |
| Correspondent | Christina L Lowe GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2006-07-27 |
| Summary: | summary |