ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS— 510(k) K041630
Substantially EquivalentCardiovascular Systems Incorporated
FDA 510(k) clearance K041630 for ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS, Substantially Equivalent on 2005-01-31. Applicant: Cardiovascular Systems Incorporated.
Clearance details
- Applicant
- Cardiovascular Systems Incorporated
- Product code
- Code MCW
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Stoughton, WI, US
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
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.