Cri Steerable Catheter Control System
FDA 510(k) K904787 · Catheter Research C/O Burditt, Bowles & Radzius
510(k) numberK904787
Submission
- Device name
- Cri Steerable Catheter Control System
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
Indianapolis, IN, US - Received
- October 23, 1990
- Decision date
- December 17, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
| K152999 | CorPath 200 SystemDXX · Traditional | Corindus, Inc. | 03/18/2016SE |
More from Corindus, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924227 | Cri Cynosar CatheterDRA · Traditional | 06/29/1993SE |
| K924125 | Cri Electronic Control SystemDXX · Traditional | 05/26/1993SE |
| K914523 | Cri Vessel Occlusin System/Cri Occlusion CoilDSS · Traditional | 01/10/1992SE |
| K904785 | Cri Cynosar CatheterDRA · Traditional | 03/06/1991SE |
| K900320 | Cri Cynosar CatheterDRA · Traditional | 09/14/1990SE |
| K884337 | Micro-Guide SystemDRA · Traditional | 01/05/1989SE |
| K870700 | Micro-GuideDQO · Traditional | 12/03/1987SE |
Questions and answers
When was Cri Steerable Catheter Control System cleared by the FDA?
Cri Steerable Catheter Control System (K904787) received a 510(k) decision of Substantially Equivalent on December 17, 1990, 55 days after the submission was received.
What is the product code of K904787?
The FDA product code is DXX – System, Catheter Control, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1290.