MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF— 510(k) K080437
Substantially EquivalentMicrus Endovascular Corporation
FDA 510(k) clearance K080437 for MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF, Substantially Equivalent on 2008-05-08. Applicant: Micrus Endovascular Corporation. Device class: 2.
Clearance details
- Applicant
- Micrus Endovascular Corporation
- Product code
- Code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code HCG
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
- 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
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
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.