510(k) Report

FDA applicant

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

Irvine, CA33 decisions2011–202514 recalls

FDA records 33 decisions for Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, CA) from 2011 to 2025: 32 510(k) clearances and 1 original PMA approval. Most are in product codes NRY (Catheter, Thrombus Retriever) and POL (Neurovascular Mechanical Thrombectomy Device…). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 54 predicates, 27 of them its own earlier devices. 14 recalls are linked to its devices, 11 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Micro Therapeutics, Inc. d/b/a ev3 Neurovascular’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 12014: 22015: 32016: 32017: 42018: 62019: 22020: 52021: 42024: 22025: 1
2011high 6 (2018) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2025

2013: 12014: 1, 1 Class I2015: 12016: 4, 4 Class I2018: 1, 1 Class I2020: 1, 1 Class I2021: 2, 2 Class I2022: 12025: 2, 2 Class I
2011high 4 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Micro Therapeutics, Inc. d/b/a ev3 Neurovascular by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Micro Therapeutics, Inc. d/b/a ev3…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NRYCatheter, Thrombus Retriever11decisions
  • POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment6decisions
  • DQYCatheter, Percutaneous5decisions
  • HCGDevice, Neurovascular Embolization4decisions
  • DQXWire, Guide, Catheter2decisions
  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision

Also: KRD (1), QJP (1), KRA (1), OUT (1).

How long do its 510(k) reviews take?

Since 2016, its 24 510(k)s took a median of 103 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 13 of its 24 were faster than that.

Whose devices does it build on?

Its devices cite 54 predicates; 27 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 45 times; 27 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K153071Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 20154cite it
  • K162539Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 20164cite it
  • K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 20183cite it
  • K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 20173cite it
  • K160641Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 20173cite it
  • K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 20143cite it

What has FDA decided for it lately?

  • K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025
  • K243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2024
  • K243080Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2024
  • K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
  • K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 20211 recall
  • K203358Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
  • K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
  • K193576Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020

All 33 as Micro Therapeutics, Inc. d/b/a ev3 Neurovascular →

What has been recalled?

14 recalls linked to its devices; the latest:

  • P100018Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF…Jan 30, 2025Class I
  • P100018Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF…Jan 30, 2025Class I
  • K203432AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF…Apr 27, 2022Class II
  • P100018Pipeline Flex Embolization DeviceJul 13, 2021Class I
  • P100018EV3 Pipeline Flex Embolization Device with Flex Shield TechnologyJul 13, 2021Class I
  • P100018ev3 Pipeline Flex Embolization Device. For neurological endovascular use.Feb 14, 2020Class I