FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05— 510(k) K061865
Substantially EquivalentGuidant Corp.
FDA 510(k) clearance K061865 for FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05, Substantially Equivalent on 2006-07-27. Applicant: Guidant Corp.. Device class: 2.
Clearance details
- Applicant
- Guidant Corp.
- 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
- Special
- Location
- Santa Clara, CA, US
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More clearances from Guidant Corp.
view allAdverse 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.