Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro Therapeutics, Inc. — Predicate Candidate Screening
51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
196 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113289 | ORION MICRO CATHETER | Micro Therapeutics, Inc. | 2012-08-01 | 268 | 0 |
| K113454 | 14 WIRE STANDARD, 14 WIRE LS | Micro Therapeutics, Inc. | 2012-02-24 | 95 | 0 |
| K090870 | ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150S | Micro Therapeutics, Inc. | 2009-05-01 | 32 | 0 |
| K090046 | CONCERTO DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2009-02-27 | 51 | 0 |
| K081465 | AXIUM DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2008-08-19 | 84 | 2 |
| K060747 | FX DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2007-04-24 | 400 | 2 |
| K060625 | NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR | Micro Therapeutics, Inc. | 2006-04-20 | 42 | 0 |
| K051990 | ECHELON MICRO CATHETER | Micro Therapeutics, Inc. | 2006-01-04 | 166 | 0 |
| K051560 | NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SO | Micro Therapeutics, Inc. | 2005-06-28 | 15 | 0 |
| K051425 | NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR | Micro Therapeutics, Inc. | 2005-06-22 | 21 | 0 |
| K050543 | NEXUS DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2005-04-27 | 56 | 0 |
| K042187 | ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHA | Micro Therapeutics, Inc. | 2004-09-02 | 21 | 0 |
| K041649 | SAPPHIRE NXT DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2004-07-16 | 29 | 0 |
| K040694 | MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) | Micro Therapeutics, Inc. | 2004-03-25 | 8 | 0 |
| K034036 | MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 | Micro Therapeutics, Inc. | 2004-02-13 | 46 | 1 |
| K033372 | SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCL | Micro Therapeutics, Inc. | 2004-01-09 | 79 | 0 |
| K032497 | SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT | Micro Therapeutics, Inc. | 2003-09-25 | 43 | 0 |
| K031852 | SAPPHIRE DETACHABLE FIBER COILS | Micro Therapeutics, Inc. | 2003-08-20 | 65 | 0 |
| K031992 | ECHELON MICRO CATHETER, MODEL 105-5091 | Micro Therapeutics, Inc. | 2003-08-07 | 41 | 0 |
| K030392 | SAPPHIRE DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2003-07-21 | 166 | 0 |
| K030688 | ECHELON MICRO CATHETER, MODEL 105-5092-150 | Micro Therapeutics, Inc. | 2003-03-28 | 23 | 0 |
| K024122 | NAUTICA MICRO CATHETER, MODEL 105-5094-153 | Micro Therapeutics, Inc. | 2003-03-07 | 81 | 0 |
| K024118 | ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 | Micro Therapeutics, Inc. | 2003-02-03 | 49 | 1 |
| K022003 | TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL | Micro Therapeutics, Inc. | 2002-09-13 | 86 | 0 |
| K021066 | MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM | Micro Therapeutics, Inc. | 2002-06-18 | 77 | 0 |
| K021139 | TRULINE REINFORCED VALVED INFUSION CATHETER | Micro Therapeutics, Inc. | 2002-04-17 | 8 | 0 |
| K011937 | TRULINE INFUSION CATHETERS | Micro Therapeutics, Inc. | 2001-08-28 | 68 | 0 |
| K011535 | CADENCE PRECISION INJECTOR, MODEL 103-0304 | Micro Therapeutics, Inc. | 2001-08-02 | 76 | 0 |
| K011656 | HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471 | Micro Therapeutics, Inc. | 2001-06-20 | 22 | 0 |
| K011526 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-412 | Micro Therapeutics, Inc. | 2001-06-14 | 28 | 0 |
| K010162 | EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, | Micro Therapeutics, Inc. | 2001-05-18 | 121 | 0 |
| K010497 | SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 1 | Micro Therapeutics, Inc. | 2001-03-22 | 29 | 0 |
| K010004 | FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 | Micro Therapeutics, Inc. | 2001-02-13 | 42 | 0 |
| K002723 | REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER B | Micro Therapeutics, Inc. | 2000-09-28 | 28 | 0 |
| K002212 | MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 | Micro Therapeutics, Inc. | 2000-08-03 | 13 | 0 |
| K001966 | REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 C | Micro Therapeutics, Inc. | 2000-07-20 | 22 | 0 |
| K001454 | SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LEN | Micro Therapeutics, Inc. | 2000-06-07 | 29 | 0 |
| K001237 | EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 | Micro Therapeutics, Inc. | 2000-05-18 | 30 | 0 |
| K993672 | REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 | Micro Therapeutics, Inc. | 2000-01-04 | 64 | 0 |
| K993257 | .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HY | Micro Therapeutics, Inc. | 1999-10-21 | 22 | 0 |
| K990487 | EQUINOX OCCLUSION BALLOON SYSTEM | Micro Therapeutics, Inc. | 1999-08-31 | 196 | 0 |
| K991225 | MTI 1 ML SYRINGE | Micro Therapeutics, Inc. | 1999-07-08 | 87 | 0 |
| K982543 | SILVERSTREAK HYDROPHILIC GUIDEWIRE | Micro Therapeutics, Inc. | 1998-12-11 | 143 | 1 |
| K974473 | EASY RIDER MICRO CATHETER | Micro Therapeutics, Inc. | 1998-06-17 | 203 | 0 |
| K980104 | FLOW RIDER FLOW DIRECTED MICRO CATHETER | Micro Therapeutics, Inc. | 1998-04-10 | 88 | 0 |
| K973669 | THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) | Micro Therapeutics, Inc. | 1998-02-06 | 134 | 0 |
| K963925 | THROMBOLYTIC BRUSH CATHETER | Micro Therapeutics, Inc. | 1997-08-08 | 312 | 0 |
| K964868 | 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER | Micro Therapeutics, Inc. | 1997-05-20 | 167 | 0 |
| K953335 | MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER | Micro Therapeutics, Inc. | 1996-01-23 | 190 | 0 |
| K954020 | MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE | Micro Therapeutics, Inc. | 1996-01-02 | 158 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda