Rubicon Support Catheter
510(k) K112303
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112303 | Date9 Nov 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Rubicon Support Catheter is a peripheral catheter designed to facilitate crossing of tight occlusions and provide optimal support and enhanced guidewire control in complex or tortuous vascular anatomies. It has an ultra-low lesion entry profile and a strong distal tip for superior push, with three radiopaque markers for excellent crossability.
The Rubicon Support Catheter is supplied by Boston Scientific and has been found substantially equivalent by the FDA. It is available in various sizes and configurations, including the Rubicon 14 Support Catheter and the Rubicon Control Support Catheter. The device is intended for use in cardiovascular procedures, and its design reduces the need for additional tools, improving procedural efficiency.
Other devices from Boston Scientific
Questions
AI-generated answers, 21 Sep 2026
What is the Rubicon Support Catheter used for?
The Rubicon Support Catheter is used in cardiovascular procedures to facilitate crossing of tight occlusions and provide optimal support and enhanced guidewire control in complex or tortuous vascular anatomies.
How is the Rubicon Support Catheter supplied?
The Rubicon Support Catheter is supplied by Boston Scientific and is available in various sizes and configurations, including the Rubicon 14 Support Catheter and the Rubicon Control Support Catheter.
Is the Rubicon Support Catheter sterile?
The device data does not explicitly state the sterility of the Rubicon Support Catheter, but it is intended for use in cardiovascular procedures, suggesting it would be supplied sterile.
What are the key features of the Rubicon Support Catheter?
The Rubicon Support Catheter has an ultra-low lesion entry profile, a strong distal tip for superior push, and three radiopaque markers for excellent crossability.