Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system— 510(k) K210586
Substantially EquivalentCardiovascular Systems, Inc.
FDA 510(k) clearance K210586 for Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system, Substantially Equivalent on 2021-09-14. Applicant: Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Systems, Inc.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St.Paul, MN, US
Recent devices under product code MCW
view allMore clearances from Cardiovascular Systems, Inc.
view all- K220109 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
- K212725 — ViperCross Support Catheters
- K211240 — ViperCross Support Catheters
- K211251 — ViperCath XC Peripheral Exchange Catheter
- K210282 — WIRION Embolic Protection System
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.