510(k) Report

FDA applicant

Micro Therapeutics, Inc.

Irvine, CA51 decisions1994–20128 recalls

FDA records 51 decisions for Micro Therapeutics, Inc. (Irvine, CA) from 1994 to 2012: 51 510(k) clearances. Most are in product codes KRA (Catheter, Continuous Flush) and HCG (Device, Neurovascular Embolization). Its devices cite 48 predicates, 38 of them its own earlier devices. 8 recalls are linked to its devices.

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.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2007: 12008: 12009: 22012: 2
2007high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2022

2007: 12008: 12010: 22011: 22022: 2
2007high 2 (2010) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Micro Therapeutics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Micro Therapeutics, Inc.’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?

  • KRACatheter, Continuous Flush17decisions
  • HCGDevice, Neurovascular Embolization11decisions
  • MJNCatheter, Intravascular Occluding, Temporary7decisions
  • DQXWire, Guide, Catheter6decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days4decisions
  • KRDDevice, Vascular, For Promoting Embolization2decisions

Also: MCW (2), FMF (1), DYB (1).

Whose devices does it build on?

Its devices cite 48 predicates; 38 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 100 times; 38 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.

  • K993672Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 20008cite it
  • K030688Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc. · 20036cite it
  • K993257.010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016 Silverspeed…Micro Therapeutics, Inc. · 19996cite it
  • K990487Equinox Occlusion Balloon SystemMicro Therapeutics, Inc. · 19996cite it
  • K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 20085cite it
  • K011656Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771Micro Therapeutics, Inc. · 20015cite it

What has FDA decided for it lately?

  • K113289Orion Micro CatheterMicro Therapeutics, Inc. · 2012
  • K11345414 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012
  • K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and Syringe Adapter AccessoryMicro Therapeutics, Inc. · 2009
  • K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc. · 2009
  • K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 20082 recalls
  • K060747FX Detachable Coil SystemMicro Therapeutics, Inc. · 20072 recalls
  • K060625Nexus Detachable Coil System, Morpheus 3D CSRMicro Therapeutics, Inc. · 2006
  • K051990Echelon Micro CatheterMicro Therapeutics, Inc. · 2006

All 51 as Micro Therapeutics, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K093750Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx OnlyJun 30, 2022Class II
  • K093750Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx OnlyJun 30, 2022Class II
  • K034036Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow…Sep 23, 2011Class II
  • K024118UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The…Sep 23, 2011Class II
  • K060747Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is…Mar 1, 2010
  • K081465Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is…Mar 1, 2010