Webster CS Catheter with EZ Steer, Model D-1263-01
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090898 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 Webster CS Catheter with EZ Steer (Model D-1263-01) is a deflectable mapping catheter designed for electrophysiological procedures. It features a high-torque shaft with a deflectable tip containing platinum/iridium electrodes, enabling precise stimulation and recording of cardiac electrical signals in the coronary sinus. This device aids in detailed mapping of cardiac structures, supporting diagnostic electrophysiology studies.
This catheter is supplied as a single-use, non-sterile device intended for use in cardiac electrophysiology labs. It is classified as a Class II medical device under FDA regulations (K090898, DRF) and holds a Special 510(k) clearance from the FDA’s Cardiovascular Advisory Committee. The device is not MRI-safe and must be handled according to sterile procedures prior to use. Storage and handling instructions are provided in the accompanying documentation.
Frequently asked questions
What is the Webster CS Catheter with EZ Steer (D-1263-01) used for?
The Webster CS Catheter with EZ Steer (Model D-1263-01) is designed for electrophysiological procedures to map cardiac electrical signals in the coronary sinus. Its deflectable tip and high-torque shaft enable precise stimulation and recording, aiding in detailed diagnostic studies of cardiac structures. This is particularly useful in identifying arrhythmias and guiding ablation therapies.
How is the Webster CS Catheter with EZ Steer (D-1263-01) supplied and prepared for use?
This catheter is supplied as a single-use, non-sterile device. Prior to use, it must be handled according to sterile procedures as outlined in the accompanying documentation. Sterilization is not required before use, but proper cleaning and preparation are essential to maintain safety and efficacy during cardiac electrophysiology procedures.
Is the Webster CS Catheter with EZ Steer (D-1263-01) reusable or intended for one-time use?
The Webster CS Catheter with EZ Steer (Model D-1263-01) is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it may compromise sterility, functionality, or patient safety. Always follow the manufacturer’s instructions for proper disposal after a single procedure.
What special handling or storage instructions apply to this catheter?
While specific storage conditions are detailed in the manufacturer’s documentation, the catheter should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is non-sterile, it must be prepared under sterile conditions before use. Additionally, the device is not MRI-safe, so it should be handled with caution in environments where MRI equipment is present.
What regulatory clearance does the Webster CS Catheter with EZ Steer (D-1263-01) hold?
The Webster CS Catheter with EZ Steer (Model D-1263-01) holds a Special 510(k) clearance from the FDA’s Cardiovascular Advisory Committee. This clearance confirms that the device is classified as Class II and is considered substantially equivalent to a predicate device for electrophysiological mapping purposes. Always refer to the manufacturer’s labeling for the most up-to-date regulatory information.
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: Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster ..., WEBSTER™ CS Catheter | J&J MedTech US - Johnson & Johnson Medical Devices, WEBSTER™ CS Catheter | Biosense Webster | J&J MedTech
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090898 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA 510(k) K090898 24 fields · synced Oct 1, 2026