Cleaner II Rotational Thrombectomy System
FDA 510(k) K033793 · Rex Medical
510(k) numberK033793
Submission
- Device name
- Cleaner II Rotational Thrombectomy System
- Applicant
- Rex Medical
Great Neck, NY, US - Received
- December 5, 2003
- Decision date
- December 16, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K120346 | Cleaner Rotational Thrombectomy SystemMCW · Traditional | 06/01/2012SE |
| K113103 | Splitwire Percutaneous Transluminal Angioplasty Scoring DevicePNO · Traditional | 05/22/2012SE |
| K102043 | Ultrastream Chronic Hemodialysis CatheterMSD · Special | 11/18/2010SE |
| K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)MCW · Traditional | 02/18/2010SE |
| K081410 | Option Vena Cava FilterDTK · Traditional | 06/04/2009SE |
| K071422 | 15.5F Hemo-Stream Hemodialysis Catheter SetMSD · Traditional | 08/22/2007SESK |
| K051468 | Inner-Lock Introducer SheathDYB · Special | 08/04/2005SE |
| K040252 | Cleaner Rotational Thrombectomy System KitMCW · Special | 02/26/2004SE |
| K032569 | Short Introducer SheathDYB · Special | 09/16/2003SE |
| K031610 | Rex Medical Cleaner Rotational Thrombectomy SystemMCW · Traditional | 05/27/2003SE |
Questions and answers
When was Cleaner II Rotational Thrombectomy System cleared by the FDA?
Cleaner II Rotational Thrombectomy System (K033793) received a 510(k) decision of Substantially Equivalent on December 16, 2003, 11 days after the submission was received.
What is the product code of K033793?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.