Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007 110
FDA 510(k) K033997 · Bacchus Vascular, Inc.
510(k) numberK033997
Submission
- Device name
- Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007 110
- Applicant
- Bacchus Vascular, Inc.
Santa Clara, CA, US - Received
- December 24, 2003
- Decision date
- February 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K003570 | Bacchus Thrombectomy Catheter (BTC), Model BTC-0755MCW · Traditional | 06/06/2001SE |
Questions and answers
When was Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007 110 cleared by the FDA?
Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007 110 (K033997) received a 510(k) decision of Substantially Equivalent on February 4, 2004, 42 days after the submission was received.
What is the product code of K033997?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.