The following data is part of a premarket notification filed by Guidant Corporation, Cardiac Surgery with the FDA for Guidant Microwave Ablation System.
| Device ID | K041340 |
| 510k Number | K041340 |
| Device Name: | GUIDANT MICROWAVE ABLATION SYSTEM |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | GUIDANT CORPORATION, CARDIAC SURGERY 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Nancy Gallo |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. UTRECHTSEWEG 310 Arnhem, NL Nl-6812 Ar |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-07-28 |
| Summary: | summary |