ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System— 510(k) K180416
Substantially EquivalentCardiovascular Systems, Inc.
FDA 510(k) clearance K180416 for ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System, Substantially Equivalent on 2018-04-17. 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.