Solitaire 2 Revascularization Device— 510(k) K162539
Substantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
FDA 510(k) clearance K162539 for Solitaire 2 Revascularization Device, Substantially Equivalent on 2016-11-10. Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Device class: 2.
Clearance details
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Product code
- Code POL
- Device class
- Class 2
- Regulation
- 21 CFR 882.5600
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code POL
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- K243080 — Riptide Aspiration System
- K211990 — Rist 071 Radial Access Guide Catheter
- K203432 — Axium Detachable Coil; Axium Prime Detachable Coil
Data sourced from openFDA. This site is unofficial and independent of the FDA.