Company ยท US
Micro Therapeutics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2012. Name variants (Inc, Corp, punctuation) are merged.
51510(k) clearances (0 in 12 months)
12recalls (3 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KRA | Catheter, Continuous Flush | 19 |
| HCG | Device, Neurovascular Embolization | 12 |
| MJN | Catheter, Intravascular Occluding, Temporary | 7 |
| OUT | Intracranial Aneurysm Flow Diverter | 7 |
| DQX | Wire, Guide, Catheter | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 4 |
| KRD | Device, Vascular, For Promoting Embolization | 2 |
| MCW | Catheter, Peripheral, Atherectomy | 2 |
| MFE | Agent, Injectable, Embolic | 2 |
| DYB | Introducer, Catheter | 1 |
| FMF | Syringe, Piston | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2012 | K113289 | ORION MICRO CATHETER Micro Therapeutics, Inc. | KRA |
| Feb 24, 2012 | K113454 | 14 WIRE STANDARD, 14 WIRE LS Micro Therapeutics, Inc. | DQX |
| May 1, 2009 | K090870 | ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY Micro Therapeutics, Inc. | KRA |
| Feb 27, 2009 | K090046 | CONCERTO DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | KRD |
| Aug 19, 2008 | K081465 | AXIUM DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | KRD |
| Apr 24, 2007 | K060747 | FX DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | HCG |
| Apr 20, 2006 | K060625 | NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR Micro Therapeutics, Inc. | HCG |
| Jan 4, 2006 | K051990 | ECHELON MICRO CATHETER Micro Therapeutics, Inc. | KRA |
| Jun 28, 2005 | K051560 | NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR Micro Therapeutics, Inc. | HCG |
| Jun 22, 2005 | K051425 | NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR Micro Therapeutics, Inc. | HCG |
| Apr 27, 2005 | K050543 | NEXUS DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | HCG |
| Sep 2, 2004 | K042187 | ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 Micro Therapeutics, Inc. | KRA |
| Jul 16, 2004 | K041649 | SAPPHIRE NXT DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | HCG |
| Mar 25, 2004 | K040694 | MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) Micro Therapeutics, Inc. | HCG |
| Feb 13, 2004 | K034036 | MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 Micro Therapeutics, Inc. | KRA |
| Jan 9, 2004 | K033372 | SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS Micro Therapeutics, Inc. | HCG |
| Sep 25, 2003 | K032497 | SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT Micro Therapeutics, Inc. | HCG |
| Aug 20, 2003 | K031852 | SAPPHIRE DETACHABLE FIBER COILS Micro Therapeutics, Inc. | HCG |
| Aug 7, 2003 | K031992 | ECHELON MICRO CATHETER, MODEL 105-5091 Micro Therapeutics, Inc. | KRA |
| Jul 21, 2003 | K030392 | SAPPHIRE DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | HCG |
| Mar 28, 2003 | K030688 | ECHELON MICRO CATHETER, MODEL 105-5092-150 Micro Therapeutics, Inc. | KRA |
| Mar 7, 2003 | K024122 | NAUTICA MICRO CATHETER, MODEL 105-5094-153 Micro Therapeutics, Inc. | KRA |
| Feb 3, 2003 | K024118 | ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 Micro Therapeutics, Inc. | KRA |
| Sep 13, 2002 | K022003 | TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 Micro Therapeutics, Inc. | DYB |
| Jun 18, 2002 | K021066 | MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM Micro Therapeutics, Inc. | MJN |
| Apr 17, 2002 | K021139 | TRULINE REINFORCED VALVED INFUSION CATHETER Micro Therapeutics, Inc. | FOZ |
| Aug 28, 2001 | K011937 | TRULINE INFUSION CATHETERS Micro Therapeutics, Inc. | FOZ |
| Aug 2, 2001 | K011535 | CADENCE PRECISION INJECTOR, MODEL 103-0304 Micro Therapeutics, Inc. | MJN |
| Jun 20, 2001 | K011656 | HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 Micro Therapeutics, Inc. | MJN |
| Jun 14, 2001 | K011526 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 Micro Therapeutics, Inc. | MJN |
| May 18, 2001 | K010162 | EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 Micro Therapeutics, Inc. | MJN |
| Mar 22, 2001 | K010497 | SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 Micro Therapeutics, Inc. | DQX |
| Feb 13, 2001 | K010004 | FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 Micro Therapeutics, Inc. | KRA |
| Sep 28, 2000 | K002723 | REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA Micro Therapeutics, Inc. | KRA |
| Aug 3, 2000 | K002212 | MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 Micro Therapeutics, Inc. | DQX |
| Jul 20, 2000 | K001966 | REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND Micro Therapeutics, Inc. | KRA |
| Jun 7, 2000 | K001454 | SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D Micro Therapeutics, Inc. | DQX |
| May 18, 2000 | K001237 | EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO Micro Therapeutics, Inc. | MJN |
| Jan 4, 2000 | K993672 | REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 Micro Therapeutics, Inc. | KRA |
| Oct 21, 1999 | K993257 | .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI Micro Therapeutics, Inc. | DQX |
| Aug 31, 1999 | K990487 | EQUINOX OCCLUSION BALLOON SYSTEM Micro Therapeutics, Inc. | MJN |
| Jul 8, 1999 | K991225 | MTI 1 ML SYRINGE Micro Therapeutics, Inc. | FMF |
| Dec 11, 1998 | K982543 | SILVERSTREAK HYDROPHILIC GUIDEWIRE Micro Therapeutics, Inc. | DQX |
| Jun 17, 1998 | K974473 | EASY RIDER MICRO CATHETER Micro Therapeutics, Inc. | KRA |
| Apr 10, 1998 | K980104 | FLOW RIDER FLOW DIRECTED MICRO CATHETER Micro Therapeutics, Inc. | KRA |
| Feb 6, 1998 | K973669 | THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) Micro Therapeutics, Inc. | MCW |
| Aug 8, 1997 | K963925 | THROMBOLYTIC BRUSH CATHETER Micro Therapeutics, Inc. | MCW |
| May 20, 1997 | K964868 | 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER Micro Therapeutics, Inc. | KRA |
| Jan 23, 1996 | K953335 | MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER Micro Therapeutics, Inc. | FOZ |
| Jan 2, 1996 | K954020 | MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE Micro Therapeutics, Inc. | KRA |
Newest 50 of 51.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2026 | Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12
UDI-DI code: 00763000448806
he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combin Open, Classified |
OUT | None listed |
| Jul 22, 2026 | Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027
REF PED2-300-20. Intracranial aneurysm flow diverter Open, Classified |
OUT | None listed |
| Jul 22, 2026 | Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027
REF PED2-300-12. Intracranial aneurysm flow diverter Open, Classified |
OUT | None listed |
| Mar 5, 2025 | Micro Therapeutics, Inc. Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3- Open, Classified |
OUT | None listed |
| Mar 5, 2025 | Micro Therapeutics, Inc. Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3- Open, Classified |
OUT | None listed |
| Mar 4, 2024 | Micro Therapeutics, Inc. The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid pro Open, Classified |
MFE | None listed |
| Mar 4, 2024 | Micro Therapeutics, Inc. The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid pro Open, Classified |
MFE | None listed |
| Jun 30, 2022 | Micro Therapeutics, Inc. Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only Open, Classified |
KRA | K030688 K093750 |
| Jun 30, 2022 | Micro Therapeutics, Inc. Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only Open, Classified |
KRA | K030688 K093750 |
| Apr 27, 2022 | Micro Therapeutics, Inc. AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX;
Axium Detachable Coil System REF QC-10-30-3D; Open, Classified |
HCG | K203432 |
| Jul 13, 2021 | Micro Therapeutics Inc, EV3 Pipeline Flex Embolization Device with Flex Shield Technology Open, Classified |
OUT | None listed |
| Jul 13, 2021 | Micro Therapeutics Inc, Pipeline Flex Embolization Device Open, Classified |
OUT | None listed |