Redifurl and Teperseal DL Intra-Aortic Balloon Catheters with Hydromer Coating
510(k) K935184
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935184 | Date10 Feb 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3535
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Redifurl and Teperseal DL Intra-Aortic Balloon Catheters with Hydromer Coating are classified as a System, Balloon, Intra-Aortic And Control device. These catheters are designed to assist in the management of acute myocardial infarction and cardiogenic shock by augmenting cardiac output through timed balloon inflation and deflation within the aorta, improving coronary and systemic perfusion.
These catheters are intended for single-use in clinical settings such as cardiac catheterization laboratories and intensive care units. They are supplied sterile and are regulated under FDA 510(k) clearance (K935184) as substantially equivalent to a predicate device. The devices are available in various sizes and configurations, as referenced by their unique identification numbers, and comply with regulation 870.3535 for intra-aortic balloon pump systems.
Other devices from St. Jude Medical, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical scenarios are these intra-aortic balloon catheters primarily intended to support, and where would they typically be used in a hospital setting?
These catheters are designed to assist in managing acute myocardial infarction and cardiogenic shock by improving coronary and systemic perfusion through timed balloon inflation and deflation within the aorta. They are intended for use in high-acuity settings like cardiac catheterization laboratories and intensive care units, where real-time hemodynamic support is critical.
Are these catheters reusable, or are they meant for single-use only? How does this affect their clinical workflow?
The Redifurl and Teperseal DL Intra-Aortic Balloon Catheters are explicitly intended for single-use in clinical settings. This design ensures sterility and reduces the risk of cross-contamination, streamlining workflows by eliminating the need for reprocessing or sterilization between patients.
What does the Hydromer coating provide, and how might it influence patient care or device handling?
The Hydromer coating is part of the catheter’s design to enhance performance in intra-aortic applications. While the exact clinical benefits aren’t detailed here, coatings like this often improve lubricity, reduce friction during insertion, or support biocompatibility—all of which can ease catheter placement and minimize patient discomfort during procedures.
How many different sizes or models are available, and why might a clinician need to select a specific one?
The device comes in multiple sizes and configurations, as indicated by the 10+ unique identification numbers listed in the registry (e.g., 3002807167, 3003945344). Clinicians select a specific model based on patient anatomy, such as aortic diameter or catheter insertion requirements, to ensure proper fit, inflation dynamics, and optimal hemodynamic support.
How should these catheters be stored, and what precautions should be taken to maintain their sterility and functionality?
Since they are supplied sterile, storage should follow manufacturer guidelines to preserve sterility (e.g., sealed packaging, protected from moisture/dust). The single-use nature means they must remain unopened until immediate clinical use. Avoid exposure to extreme temperatures or direct sunlight, as these could degrade the Hydromer coating or balloon material over time.