Thrombolytic Brush Catheter
FDA 510(k) K963925 · Micro Therapeutics, Inc.
510(k) numberK963925
Submission
- Device name
- Thrombolytic Brush Catheter
- Applicant
- Micro Therapeutics, Inc.
San Clemente, CA, US - Received
- September 30, 1996
- Decision date
- August 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Other 510(k)s with product code MCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260244 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical | 04/10/2026SE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | Cardio Flow Inc., | 04/25/2025SE |
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | Spectranetics | 03/13/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | Bard Peripheral Vascular, Inc. | 01/30/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | Cardio Flow Inc., | 11/05/2024SE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special | Eximo Medical, Ltd. | 06/27/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | Cardio Flow Inc., | 02/15/2024SE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special | Eximo Medical, Ltd. | 12/15/2023SE |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Traditional | Cardio Flow Inc., | 09/27/2023SE |
| K230709 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 06/09/2023SE |
More from Eximo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K113289 | Orion Micro CatheterKRA · Traditional | 08/01/2012SE |
| K113454 | 14 Wire Standard, 14 Wire LSDQX · Traditional | 02/24/2012SE |
| K090870 | Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and…KRA · Special | 05/01/2009SE |
| K090046 | Concerto Detachable Coil SystemKRD · Special | 02/27/2009SE |
| K081465 | Axium Detachable Coil SystemKRD · Traditional | 08/19/2008SE |
| K060747 | FX Detachable Coil SystemHCG · Traditional | 04/24/2007SE |
| K060625 | Nexus Detachable Coil System, Morpheus 3D CSRHCG · Special | 04/20/2006SE |
| K051990 | Echelon Micro CatheterKRA · Traditional | 01/04/2006SE |
| K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRHCG · Special | 06/28/2005SE |
| K051425 | Nexus Detachable Coil System, Helix Super Soft CSRHCG · Special | 06/22/2005SE |
Questions and answers
When was Thrombolytic Brush Catheter cleared by the FDA?
Thrombolytic Brush Catheter (K963925) received a 510(k) decision of Substantially Equivalent on August 8, 1997, 312 days after the submission was received.
What is the product code of K963925?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.