Bacchus Thrombectomy Catheter (BTC), Model BTC-0755
FDA 510(k) K003570 · Bacchus Vascular, Inc.
510(k) numberK003570
Submission
- Device name
- Bacchus Thrombectomy Catheter (BTC), Model BTC-0755
- Applicant
- Bacchus Vascular, Inc.
Santa Clara, CA, US - Received
- November 20, 2000
- Decision date
- June 6, 2001
- 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 |
|---|---|---|
| K082199 | Spiralfuse Peripheral Infusion SystemQEY · Traditional | 10/17/2008SE |
| K071664 | TRELLIS-6 Peripheral Infusion SystemQEY · Special | 07/13/2007SE |
| K050147 | TRELLIS-8 Peripheral Infusion SystemQEY · Special | 02/03/2005SE |
| K033997 | Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007…MCW · Special | 02/04/2004SE |
| K032261 | Trellis Reserve Infusion SystemQEY · Special | 08/22/2003SE |
| K023514 | TRELLIS-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)QEY · Traditional | 12/02/2002SE |
| K022640 | Solera Magnum Thrombectomy Catheter, 55 CM, Model Bac SMG 007 055 & Solera Magnum…MCW · Special | 12/02/2002SE |
| K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…QEY · Special | 07/03/2002SE |
| K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…QEY · Traditional | 02/11/2002SE |
Questions and answers
When was Bacchus Thrombectomy Catheter (BTC), Model BTC-0755 cleared by the FDA?
Bacchus Thrombectomy Catheter (BTC), Model BTC-0755 (K003570) received a 510(k) decision of Substantially Equivalent on June 6, 2001, 198 days after the submission was received.
What is the product code of K003570?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.