Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300
FDA 510(k) K043553 · Fox Hollow Technologies
510(k) numberK043553
Submission
- Device name
- Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300
- Applicant
- Fox Hollow Technologies
Redwood City, CA, US - Received
- December 27, 2004
- Decision date
- February 18, 2005
- 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 |
|---|---|---|
| K071432 | Silverhawk-R Peripheral Plaque Excision System for Surgical UseMCW · Traditional | 02/12/2008SE |
| K071826 | The Rinspirator, Models FG09770, FG08776, FG08777, FG08910QEZ · Special | 11/09/2007SE |
| K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…MCW · Special | 01/13/2006SE |
| K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter…MCW · Traditional | 06/20/2003SE |
Questions and answers
When was Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 cleared by the FDA?
Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 (K043553) received a 510(k) decision of Substantially Equivalent on February 18, 2005, 53 days after the submission was received.
What is the product code of K043553?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.