CorPath 200 System
FDA 510(k) K152999 · Corindus, Inc.
510(k) numberK152999
Submission
- Device name
- CorPath 200 System
- Applicant
- Corindus, Inc.
Waltham, MA, US - Received
- October 13, 2015
- Decision date
- March 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXX – System, Catheter Control, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1290
- Specialty
- Cardiovascular
Other 510(k)s with product code DXX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262744 | GenesisX RMNDXX · Special | Stereotaxis, Inc. | 08/27/2026SE |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS)DXX · Traditional | Stereotaxis, Inc. | 11/06/2025SE |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS)DXX · Traditional | Microbot Medical , Ltd. | 09/04/2025SE |
| K221464 | CorPath GRX SystemDXX · Special | Corindus, Inc. | 07/27/2022SE |
| K202275 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 12/11/2020SE |
| K180517 | CorPath GRX SystemDXX · Special | Corindus, Inc. | 03/29/2018SE |
| K173806 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 03/01/2018SE |
| K173288 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 02/15/2018SE |
| K160121 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 10/27/2016SE |
| K150892 | CorPath 200 SystemDXX · Traditional | Corindus, Inc. | 10/02/2015SE |
More from Corindus, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221464 | CorPath GRX SystemDXX · Special | 07/27/2022SE |
| K202275 | CorPath GRX SystemDXX · Traditional | 12/11/2020SE |
| K180517 | CorPath GRX SystemDXX · Special | 03/29/2018SE |
| K173806 | CorPath GRX SystemDXX · Traditional | 03/01/2018SE |
| K173288 | CorPath GRX SystemDXX · Traditional | 02/15/2018SE |
| K160121 | CorPath GRX SystemDXX · Traditional | 10/27/2016SE |
| K150892 | CorPath 200 SystemDXX · Traditional | 10/02/2015SE |
| K120834 | Corpath 200 SystemDXX · Traditional | 07/19/2012SE |
Questions and answers
When was CorPath 200 System cleared by the FDA?
CorPath 200 System (K152999) received a 510(k) decision of Substantially Equivalent on March 18, 2016, 157 days after the submission was received.
What is the product code of K152999?
The FDA product code is DXX – System, Catheter Control, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1290.