EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19— 510(k) K090665
Substantially EquivalentAbbott Vascular-Vascular Solutions
FDA 510(k) clearance K090665 for EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19, Substantially Equivalent on 2009-05-22. Applicant: Abbott Vascular-Vascular Solutions. Device class: 2.
Clearance details
- Applicant
- Abbott Vascular-Vascular Solutions
- Product code
- Code NTE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clara, CA, US
Recent devices under product code NTE
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- K080264 — MODIFICATION TO: FOX PLUS PTA CATHETER
- K072798 — VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
Adverse events under product code NTE
product code NTE- Death
- 28
- Injury
- 1,348
- Malfunction
- 771
- Total
- 2,147
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.