MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO— 510(k) K103780
Substantially EquivalentMicrus Endovascular Corporation
FDA 510(k) clearance K103780 for MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO, Substantially Equivalent on 2011-01-26. Applicant: Micrus Endovascular Corporation. Device class: 2.
Clearance details
- Applicant
- Micrus Endovascular Corporation
- Product code
- Code MJN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code MJN
view allMore clearances from Micrus Endovascular Corporation
view all- K102818 — MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
- 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 MJN
product code MJN- Death
- 31
- Injury
- 240
- Malfunction
- 827
- Total
- 1,098
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.