GUIDANT MICROWAVE ABLATION SYSTEM— 510(k) K041340
Substantially EquivalentGuidant Corporation, Cardiac Surgery
FDA 510(k) clearance K041340 for GUIDANT MICROWAVE ABLATION SYSTEM, Substantially Equivalent on 2004-07-28. Applicant: Guidant Corporation, Cardiac Surgery. Device class: 2.
Clearance details
- Applicant
- Guidant Corporation, Cardiac Surgery
- Product code
- Code NEY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code NEY
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- K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
- K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS)
- K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A)
- K241825 — Microwave Ablation Antennas
More clearances from Guidant Corporation, Cardiac Surgery
view all- K080169 — HEARTSTRING III PROXIMAL SEAL SYSTEM
- K023630 — ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
- K024071 — GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
- K023629 — ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
- K022718 — VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
Adverse events under product code NEY
product code NEY- Death
- 24
- Injury
- 388
- Malfunction
- 462
- Other
- 1
- Total
- 875
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.