CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080425 FDA 510(k)
- FDA Product Code
- DRF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1220 FDA 510(k)
- Regulation Number
- 870.1220 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CS Refstar Catheter (D- and F-Curves) is a Catheter, Electrode Recording, or Probe, Electrode Recording, designed for electrophysiological mapping and ablation procedures in the cardiovascular system. It features a deflectable tip controlled via a proximal handpiece, enabling precise navigation within cardiac chambers to record electrical activity or deliver therapeutic energy.
This device is supplied as a single-use, non-sterile product intended for use in electrophysiology laboratories. It is classified under FDA regulation 870.1220 and holds a FDA 510K clearance (K080425) as substantially equivalent to predicate devices. The D-1285-01 and D-1285-02 models are available in two distinct tip deflection curves (D-curve and F-curve) to accommodate varying procedural needs. Sterilization and preparation must follow manufacturer guidelines prior to use.
Frequently asked questions
What is the CS Refstar Catheter (D/F-Curves) used for?
The CS Refstar Catheter (D/F-Curves) is designed specifically for electrophysiological mapping and ablation procedures within the cardiovascular system. Its deflectable tip, controlled via a proximal handpiece, allows clinicians to navigate cardiac chambers with precision, enabling accurate recording of electrical activity or targeted delivery of therapeutic energy during arrhythmia treatments.
How is the CS Refstar Catheter supplied, and what does this mean for use?
This catheter is supplied as a single-use, non-sterile product. This means each catheter is intended for one procedure only and must be sterilized and prepared according to the manufacturer’s guidelines before use. Sterilization is critical to ensure patient safety and device efficacy during electrophysiology interventions.
What are the differences between the D-1285-01 and D-1285-02 models?
The D-1285-01 and D-1285-02 models differ by their tip deflection curves: the D-1285-01 features a D-curve deflection, while the D-1285-02 features an F-curve deflection. These distinct curves accommodate varying procedural needs, allowing clinicians to select the catheter best suited for the anatomical challenges of their specific electrophysiology case.
Is the CS Refstar Catheter reusable, or is it intended for single-use?
The CS Refstar Catheter is explicitly designed for single-use only. This classification ensures patient safety by eliminating risks associated with repeated sterilization and reuse, which can compromise device integrity or introduce contamination. Always follow manufacturer instructions for preparation and use.
How should the CS Refstar Catheter be stored before use?
Storage instructions are provided by the manufacturer to maintain the catheter’s integrity and sterility (if applicable post-preparation). Generally, single-use medical devices like this should be stored in a clean, dry environment, protected from extreme temperatures, direct sunlight, and physical damage. Always refer to the included packaging or manufacturer guidelines for specific storage recommendations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cs Refstar Catheter (D- and F-curves), Models D-1285-01 and D-1285-02 ..., Cs Refstar Catheter (D- and F-curves), Models D-1285-01 and D-1285-02, Cs Refstar Catheter (D- and F-curves), Models D-1285-01 and D-1285-02, K080425 - CS REFSTAR CATHETER (D- AND F-CURVES) | FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080425 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA 510(k) K080425 24 fields · synced Oct 1, 2026