Turbohawk Peropheral Plaque Excision System
FDA 510(k) K103618 · Ev3, Inc.
510(k) numberK103618
Submission
- Device name
- Turbohawk Peropheral Plaque Excision System
- Applicant
- Ev3, Inc.
Plymouth, MN, US - Received
- December 10, 2010
- Decision date
- January 5, 2011
- 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 |
|---|---|---|
| K141118 | Nanocross Eite 0.014 Over-The-Wire Pta Balloon Dilatation CatheterLIT · Special | 07/18/2014SE |
| K132777 | Nanocross Elite .14 Over-The-Wire Pta, Balloon Dilation CatheterLIT · Traditional | 09/26/2013SE |
| K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterLIT · Traditional | 05/24/2013SE |
| K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterLIT · Traditional | 02/12/2013SE |
| K111723 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | 10/27/2011SE |
| K111010 | Spiderfx Embolic Protection DeviceNTE · Traditional | 10/27/2011SE |
| K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…KRA · Special | 09/16/2011SE |
| K110319 | Evercross 0.035 Otw Pta Dilatation CatheterLIT · Special | 04/14/2011SE |
| K103322 | Evercross 0.035 Otw Pta Dilation CatheterLIT · Traditional | 12/06/2010SE |
| K100063 | Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide…MJN · Special | 02/02/2010SE |
Questions and answers
When was Turbohawk Peropheral Plaque Excision System cleared by the FDA?
Turbohawk Peropheral Plaque Excision System (K103618) received a 510(k) decision of Substantially Equivalent on January 5, 2011, 26 days after the submission was received.
What is the product code of K103618?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.