SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- SureFlex™ EUDAMED
- Device Name
- SureFlex Steerable Guiding Sheath EUDAMED
- Model / Reference
- SureFlex Steerable Guiding Sheath EUDAMEDTSK3005 EUDAMEDTSK3001 EUDAMEDTSK3003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00685447018568 EUDAMED00685447018544 EUDAMED00685447018551 EUDAMED
- Basic UDI-DI
- B-00685447018568 EUDAMEDB-00685447018544 EUDAMEDB-00685447018551 EUDAMED
- 510(k) Number
- K231227 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath are steerable catheter introducers designed for transseptal procedures. These devices feature an 8.5 Fr diameter sheath with bi-directional deflection (180 degrees) and four equi-spaced electrodes for enhanced visualization during cardiac interventions.
Intended for single-use in sterile clinical settings, the system includes a steerable sheath, transseptal dilator, and J-tip guidewire. Authorized under FDA 510(k) clearance (K231227) and classified as a Class 2 device under product code DYB, these sheaths are regulated under the Medical Device Directive (MDD) and are supplied sterile for procedural use.
Frequently asked questions
What types of procedures are these steerable sheaths primarily designed for, and why is the 8.5 Fr diameter important?
These sheaths are specifically designed for transseptal procedures, which involve accessing the heart chambers from the venous side through the atrial septum. The 8.5 Fr diameter provides a balance between flexibility for navigation and sufficient lumen size to accommodate guidewires, dilators, and catheters commonly used in such interventions, ensuring compatibility with standard cardiac tools while maintaining steerability.
Are these sheaths reusable, or are they intended for single-use only? How does this affect their clinical use?
The SureFlex HD and VersaCross HD Steerable Sheaths are explicitly intended for single-use only in sterile clinical settings. This design choice reduces the risk of cross-contamination and ensures consistent performance per procedure, as reuse could compromise sterility and structural integrity, potentially leading to complications during delicate cardiac interventions.
What components are included in the system, and how does the bi-directional deflection feature benefit the user?
The system includes the steerable sheath itself, a transseptal dilator, and a J-tip guidewire. The bi-directional deflection (180 degrees) allows clinicians to maneuver the sheath precisely in multiple directions, improving access to targeted areas within the heart during transseptal procedures. This feature enhances procedural control, particularly in complex anatomies or when navigating tortuous pathways.
How should these sheaths be stored, and what precautions should be taken to maintain their sterility?
The sheaths are supplied sterile for immediate procedural use, so they should be stored in their original packaging until ready for deployment. To preserve sterility, avoid exposing the sheath to moisture, direct sunlight, or extreme temperatures. Once opened, the system must be used immediately in a sterile field, as single-use devices are not intended for reprocessing or delayed use.
What regulatory pathways have these devices undergone, and what does the product code DYB indicate about their classification?
The SureFlex HD and VersaCross HD Steerable Sheaths were cleared via an FDA 510(k) submission (K231227) under the Traditional Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. The product code DYB classifies them as Class II devices under the FDA’s regulatory framework, indicating moderate risk and requiring compliance with specific manufacturing and labeling controls to ensure safety and effectiveness.
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: SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (K231227 ..., sureflex hd steerable sheath versacross hd steerable sheath, fda.innolitics.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231227 | Class II | Active |
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Manufacturer
- Manufacturer
- Baylis Medical Company Inc.
- FDA Applicant
- Baylis Medical Company, Inc.
Sources (4)
- FDA 510(k) K231227 24 fields · synced Sep 18, 2026
- EUDAMED 8737508d-4a08-4d5f-ac3b-c79380ae776f 61 fields · synced Jul 13, 2026
- EUDAMED e2313079-269c-4e5d-8ecb-682805f4c001 61 fields · synced Jul 21, 2026
- EUDAMED 1e2cc934-bf78-4085-aff9-5a72ffd72f25 61 fields · synced Jul 24, 2026