Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series— 510(k) K182397
Substantially EquivalentCardiovascular Systems, Inc.
FDA 510(k) clearance K182397 for Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series, Substantially Equivalent on 2018-12-13. Applicant: Cardiovascular Systems, Inc..
Clearance details
- Applicant
- Cardiovascular Systems, Inc.
- Product code
- Code MCW
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St.Paul, MN, 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.