VersaCross Connect Transseptal Dilator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241720 FDA 510(k)
- FDA Product Code
- DRE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1310 FDA 510(k)
- Regulation Number
- 870.1310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VersaCross Connect Transseptal Dilator is a dilator, vessel, for percutaneous catheterization, designed for transseptal access procedures. It facilitates the creation of a pathway across the interatrial septum to enable catheter-based interventions in the left atrium, commonly used in structural heart disease treatments.
This device is supplied as a single-use, sterile instrument, intended for use in controlled clinical settings such as cardiac catheterization labs. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. Available in specified sizes and configurations, it is intended for percutaneous use and must be handled according to sterile medical protocols.
Frequently asked questions
What clinical procedures is the VersaCross Connect Transseptal Dilator primarily used for?
The VersaCross Connect Transseptal Dilator is designed specifically for transseptal access procedures, creating a pathway across the interatrial septum to enable catheter-based interventions in the left atrium. This is particularly useful in structural heart disease treatments, such as mitral valve repairs or left atrial appendage closures.
Is the VersaCross Connect Transseptal Dilator intended for single-use or reusable applications?
The device is explicitly supplied as a single-use, sterile instrument, meaning it is intended for one-time use in a controlled clinical setting like a cardiac catheterization lab. Reuse is not recommended or supported by the manufacturer.
What regulatory pathways has the VersaCross Connect Transseptal Dilator followed, and what does that mean for its use?
The device has received FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and performance. This means it has undergone evaluation by the FDA and the EU’s Medical Device Regulation (MDR) to ensure compliance with applicable requirements before commercial distribution.
How should the VersaCross Connect Transseptal Dilator be stored before use?
Since it is a sterile, single-use device, it must be stored in its original packaging until ready for use. The packaging should be kept in a clean, dry environment, protected from contamination, and away from extreme temperatures or direct sunlight to maintain sterility and integrity.
Are there multiple sizes or configurations available for the VersaCross Connect Transseptal Dilator?
Yes, the device is available in specified sizes and configurations, though exact measurements or variations are not detailed in the provided data. Clinicians should refer to the manufacturer’s product documentation or catalog for precise sizing options to ensure compatibility with patient anatomy and procedural requirements.
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: VersaCross™ Access Solution - Boston Scientific, MAUDE Adverse Event Report: Baylis Medicale Cie Inc VersaCross Connect ..., VersaCross Connect™ Transseptal Dilator (K251325) — FDA 510 (k ..., Baylis VXAK0007 VersaCross Connect™ LAAC Access Solution
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241720 | Class II | Active |
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Manufacturer
- Manufacturer
- Baylis Medical Company Inc.
- FDA Applicant
- Baylis Medical Company, Inc.
Sources (2)
- FDA 510(k) K241720 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 29, 2026