Rubicon 14, 18, and 35 Support Catheters
510(k) K171913
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK171913 | Date25 Jul 2017 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DQY
- FDA applicant
- Boston Scientific Corporation
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Rubicon 14, 18, and 35 Support Catheters are designed as support catheters for use in coronary interventions, providing structural reinforcement during percutaneous coronary procedures. These devices are intended to maintain vessel patency and assist in the delivery of stents or balloons by offering radial support to the coronary artery.
Supplied as single-use devices, these catheters are intended for use in clinical settings such as cardiac catheterization labs. They are regulated under the FDA’s 510K clearance (K171913) and the EU’s MDR, with sizes corresponding to their respective reference numbers (14, 18, and 35). Sterility and MRI safety are not specified in the data, but they are intended for one-time use per procedure.
Other devices from Boston Scientific
Questions
AI-generated answers, 18 Sep 2026
What are the primary uses of the Rubicon 14, 18, and 35 Support Catheters in a cardiac procedure?
The Rubicon Support Catheters are specifically designed to provide structural reinforcement during coronary interventions, such as stent placement or balloon angioplasty. Their purpose is to maintain vessel patency and offer radial support to the coronary artery, ensuring stable delivery of therapeutic devices while minimizing vessel collapse or deformation during the procedure.
Are these catheters reusable, or are they intended for single-use only?
These catheters are explicitly supplied as single-use devices, meaning they are intended for one-time use per procedure. This design aligns with clinical best practices in cardiac catheterization labs to ensure sterility and safety for patients.
What sizes are available for the Rubicon Support Catheters, and how do they relate to their intended use?
The Rubicon Support Catheters come in three sizes: 14, 18, and 35, corresponding to their reference numbers. These sizes likely refer to the outer diameter or a related measurement that aligns with the specific coronary artery diameters or procedural requirements they are designed to support.
How were these catheters classified in the FDA’s regulatory process, and what does that mean for their use?
The Rubicon Support Catheters were classified under the FDA’s 510K pathway with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). This classification means the device was determined to be comparable to a legally marketed predicate device, ensuring they meet established safety and performance standards for coronary support catheters in percutaneous interventions.
Where were these catheters submitted for FDA clearance, and who was the applicant?
The submission for the Rubicon Support Catheters was filed with the FDA under the Cardiovascular (CV) Advisory Committee and processed through a Special 510K clearance. The applicant was Boston Scientific Corporation, based in Maple Grove, Minnesota, with the submission received on June 26, 2017, and cleared on July 25, 2017.