ENROUTE® Transcarotid Neuroprotection System— 510(k) K230402
Substantially EquivalentSilk Road Medical
FDA 510(k) clearance K230402 for ENROUTE® Transcarotid Neuroprotection System, Substantially Equivalent on 2023-04-11. Applicant: Silk Road Medical. Device class: 2.
Clearance details
- Applicant
- Silk Road Medical
- 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
- Sunnyvale, CA, US
Recent devices under product code NTE
view all- K222694 — EmPro EPS (EP4514C-190, EP6514C-190); Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- K220654 — ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
- K210282 — WIRION Embolic Protection System
- K200198 — WIRION
- K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
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 K230402
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 K230402.
Data sourced from openFDA. This site is unofficial and independent of the FDA.