WIRION Embolic Protection System— 510(k) K210282
Substantially EquivalentCardiovascular Systems, Inc.
FDA 510(k) clearance K210282 for WIRION Embolic Protection System, Substantially Equivalent on 2021-03-03. Applicant: Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Systems, Inc.
- Product code
- Code NTE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St.Paul, MN, US
Recent devices under product code NTE
view all- K222694 — EmPro EPS (EP4514C-190, EP6514C-190); Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- K230402 — ENROUTE® Transcarotid Neuroprotection System
- K220654 — ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
- K200198 — WIRION
- K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
More 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 NTE
product code NTE- Death
- 28
- Injury
- 1,348
- Malfunction
- 771
- Total
- 2,147
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 K210282
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 K210282.
Data sourced from openFDA. This site is unofficial and independent of the FDA.