Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)— 510(k) K181807
Substantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
FDA 510(k) clearance K181807 for Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device), Substantially Equivalent on 2019-03-06. 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
view allMore clearances from Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
view all- K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
- K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
- 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.