Stealth 360 Orbital Pad System
FDA 510(k) K131092 · Cardio Systems, Inc.
510(k) numberK131092
Submission
- Device name
- Stealth 360 Orbital Pad System
- Applicant
- Cardio Systems, Inc.
Saint Paul, MN, US - Received
- April 18, 2013
- Decision date
- June 24, 2013
- 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 |
|---|---|---|
| K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy SystemMCW · Special | 08/14/2008SE |
| K972022 | ZAK-2000FNM · Traditional | 01/22/1998SE |
| K934689 | Low Air Loss Mattress, ModificationINX · Traditional | 02/02/1994SE |
| K921500 | Centri-Safe(Tm) ValveMJJ · Traditional | 09/15/1992SE |
| K882177 | Add-On to Critical Patient Care BedIOQ · Traditional | 12/01/1988SE |
| K852736 | Baylor Rapid Autotransfusion SystemCAC · Traditional | 09/18/1985SE |
| K792152 | Cardioplegia Solution Admin. SetDWF · Traditional | 11/13/1979SE |
| K792151 | Oxygenator Gas Line FilterKRI · Traditional | 11/13/1979SE |
Questions and answers
When was Stealth 360 Orbital Pad System cleared by the FDA?
Stealth 360 Orbital Pad System (K131092) received a 510(k) decision of Substantially Equivalent on June 24, 2013, 67 days after the submission was received.
What is the product code of K131092?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.