STEALTH 360 ORBITAL PAD SYSTEM— 510(k) K110389
Substantially EquivalentCardiovascular Systems, Inc.
FDA 510(k) clearance K110389 for STEALTH 360 ORBITAL PAD SYSTEM, Substantially Equivalent on 2011-03-11. 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
- Saint 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
- K210586 — Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
- K211240 — ViperCross Support Catheters
- K211251 — ViperCath XC Peripheral Exchange Catheter
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 →
Recalls naming K110389
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110389.
Data sourced from openFDA. This site is unofficial and independent of the FDA.