Modification to Pathway PV Atherectomy System
FDA 510(k) K082186 · Pathway Medical Technologies, Inc.
510(k) numberK082186
Submission
- Device name
- Modification to Pathway PV Atherectomy System
- Applicant
- Pathway Medical Technologies, Inc.
Kirkland, WA, US - Received
- August 1, 2008
- Decision date
- August 29, 2008
- 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 |
|---|---|---|
| K120242 | Jetstream Navitus L SystemMCW · Special | 02/24/2012SE |
| K111229 | Jetstream G3 (R) SF 1.6 SystemMCW · Special | 06/01/2011SE |
| K110626 | Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 Se System; Jetstream G3 L…MCW · Special | 04/20/2011SE |
| K101334 | Jetstream G3 Se System, Jetstream G3 SF System Model PV31230 (Jetstream G3 Se Catheter…MCW · Special | 06/11/2010SE |
| K101221 | Jetstream G3 System, Model PV31300, PV Console, Model PVCN100MCW · Special | 06/02/2010SE |
| K100462 | Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100MCW · Traditional | 05/19/2010SE |
| K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…MCW · Special | 01/21/2010SE |
| K093456 | Jetstream G3 SystemMCW · Special | 12/01/2009SE |
| K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…MCW · Special | 09/03/2009SE |
| K091509 | Jetstream G2 NXT System, Model PV20300MCW · Special | 06/19/2009SE |
Questions and answers
When was Modification to Pathway PV Atherectomy System cleared by the FDA?
Modification to Pathway PV Atherectomy System (K082186) received a 510(k) decision of Substantially Equivalent on August 29, 2008, 28 days after the submission was received.
What is the product code of K082186?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.