Micro Therapeutics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 7 (2 Class I)
- 510(k) Clearances
- 51
- Inspections
- 5
- Compliance Actions
- 0
Known Names
micro therapeutics, micro therapeutics inc
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1246-2025 | Class I | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-02 | January 30, 2025 |
| Z-1245-2025 | Class I | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-02 | January 30, 2025 |
| Z-1253-2024 | Class II | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter | January 11, 2024 |
| Z-1252-2024 | Class II | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter | January 11, 2024 |
| Z-1557-2022 | Class II | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only | June 30, 2022 |
| Z-1556-2022 | Class II | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only | June 30, 2022 |
| Z-1261-2022 | Class II | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D; | April 27, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113289 | ORION MICRO CATHETER | August 1, 2012 |
| K113454 | 14 WIRE STANDARD, 14 WIRE LS | February 24, 2012 |
| K090870 | ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER | May 1, 2009 |
| K090046 | CONCERTO DETACHABLE COIL SYSTEM | February 27, 2009 |
| K081465 | AXIUM DETACHABLE COIL SYSTEM | August 19, 2008 |
| K060747 | FX DETACHABLE COIL SYSTEM | April 24, 2007 |
| K060625 | NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR | April 20, 2006 |
| K051990 | ECHELON MICRO CATHETER | January 4, 2006 |
| K051560 | NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR | June 28, 2005 |
| K051425 | NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR | June 22, 2005 |
| K050543 | NEXUS DETACHABLE COIL SYSTEM | April 27, 2005 |
| K042187 | ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHA | September 2, 2004 |
| K041649 | SAPPHIRE NXT DETACHABLE COIL SYSTEM | July 16, 2004 |
| K040694 | MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) | March 25, 2004 |
| K034036 | MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 | February 13, 2004 |
| K033372 | SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS | January 9, 2004 |
| K032497 | SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT | September 25, 2003 |
| K031852 | SAPPHIRE DETACHABLE FIBER COILS | August 20, 2003 |
| K031992 | ECHELON MICRO CATHETER, MODEL 105-5091 | August 7, 2003 |
| K030392 | SAPPHIRE DETACHABLE COIL SYSTEM | July 21, 2003 |