# Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

- Location (FDA's records): Irvine, CA
- FDA decisions: 33 (2011–2025): 32 510(k) clearances and 1 original PMA approval
- Product codes: NRY (11), POL (6), DQY (5), HCG (4), DQX (2), JCX (1), KRD (1), QJP (1), KRA (1), OUT (1)
- 510(k) review time since 2016: median 103 days, against 110 for FDA's reviews in the same codes and years (13 of 24 faster)
- Predicates its devices cite: 54 (27 its own); citations of its devices by later devices: 45 (27 its own)
- Recalls linked to its devices: 14 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Micro Therapeutics, Inc.: 6 (https://510kreport.com/company/micro-therapeutics)
- Micro Therapeutics Dba Ev3 Neurovascular: 5 (https://510kreport.com/company/micro-therapeutics-dba-ev3-neurovascular)
- Penumbra, Inc.: 4 (https://510kreport.com/company/penumbra)
- Reverse Medical Corporation: 4 (https://510kreport.com/company/reverse-medical)
- Rist Neurovascular, Inc.: 3 (https://510kreport.com/company/rist-neurovascular)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Concentric Medical, Inc.: 1 (https://510kreport.com/company/concentric-medical)
- Micro Therapeutics, Inc. D/B/A: Ev3, Inc.: 1 (https://510kreport.com/company/micro-therapeutics-d-b-a-ev3)

## Firms that cite its devices most
- Medtronic Neurovascular: 4 (https://510kreport.com/company/medtronic-neurovascular)
- Spartan Micro, Inc.: 2 (https://510kreport.com/company/spartan-micro)
- Wallaby Medical: 2 (https://510kreport.com/company/wallaby-medical)
- Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular: 2 (https://510kreport.com/company/micro-therapeutics-lnc-d-b-a-ev3-neurovascular)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Neuravi, Ltd.: 1 (https://510kreport.com/company/neuravi)
- Rapid Medical, Ltd.: 1 (https://510kreport.com/company/rapid-medical)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)

## Its most-cited devices
- K153071: Solitaire Platinum Revascularization Device (2015), cited by 4
- K162539: Solitaire 2 Revascularization Device (2016), cited by 4
- K180715: React 68 Catheter (2018), cited by 3
- K162704: Axium Prime Detachable Coil System (2017), cited by 3
- K160641: Solitaire Platinum Revascularization Device, 6x40 mm (2017), cited by 3
- K133310: Axium Detachable Coil System (2014), cited by 3

## Recent decisions
- K241388: Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (Jan 2, 2025)
- K243418: Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (Dec 2, 2024)
- K243080: Riptide Aspiration System (Oct 29, 2024)
- K211990: Rist 071 Radial Access Guide Catheter (Jul 27, 2021)
- K203432: Axium Detachable Coil; Axium Prime Detachable Coil (Jul 7, 2021)
- K203358: Solitaire X Revascularization Device (Mar 1, 2021)
- K202850: Concerto Versa, Detachable Coil (Feb 9, 2021)
- K193576: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) (Nov 20, 2020)

Source page: https://510kreport.com/company/micro-therapeutics-d-b-a-ev3-neurovascular