MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE— 510(k) K102818
Substantially EquivalentMicrus Endovascular Corporation
FDA 510(k) clearance K102818 for MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE, Substantially Equivalent on 2010-12-03. Applicant: Micrus Endovascular Corporation. Device class: 2.
Clearance details
- Applicant
- Micrus Endovascular Corporation
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code DQX
view allMore clearances from Micrus Endovascular Corporation
view all- K103780 — MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
- K092702 — MICRUS MICROCATHETER, MODEL COURIER 270
- K091504 — MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00
- K083922 — MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
- K090274 — MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.