MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00— 510(k) K091504
Substantially EquivalentMicrus Endovascular Corporation
FDA 510(k) clearance K091504 for MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00, Substantially Equivalent on 2009-06-19. 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- K103780 — MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
- K102818 — MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
- K092702 — MICRUS MICROCATHETER, MODEL COURIER 270
- 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.