VersaCross Connect Transseptal Dilator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251325 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 in cardiovascular interventions. It facilitates the creation of a controlled pathway through the interatrial septum, enabling the passage of catheters and guidewires for diagnostic or therapeutic purposes, such as structural heart interventions or electrophysiology studies.
This device is supplied as a single-use, non-sterile product, intended for use in sterile environments such as cardiac catheterization labs. It is classified as a Class II medical device under FDA regulations (510(k) clearance) and adheres to the MDR framework. The dilator is available in multiple sizes and configurations, as referenced by the listed FEI numbers, and must be handled according to manufacturer guidelines to ensure proper sterility and functionality before use.
Frequently asked questions
What types of procedures is the VersaCross Connect Transseptal Dilator designed to assist with?
The VersaCross Connect Transseptal Dilator is specifically designed for transseptal access procedures in cardiovascular interventions. It helps create a controlled pathway through the interatrial septum to facilitate the passage of catheters and guidewires, enabling diagnostic or therapeutic interventions such as structural heart procedures or electrophysiology studies.
Is the VersaCross Connect Transseptal Dilator intended for single-use or reuse?
The device is explicitly labeled as a single-use product. It is supplied in a non-sterile state but must be used in sterile environments like cardiac catheterization labs, where proper sterilization protocols are followed before use.
How many sizes or configurations are available for the VersaCross Connect Transseptal Dilator?
The device comes in multiple sizes and configurations, each identified by unique FEI numbers. Over 100 distinct FEI numbers are listed, indicating a broad range of options to accommodate different procedural needs.
What regulatory pathways has the VersaCross Connect Transseptal Dilator followed?
The device has received FDA 510(k) clearance and adheres to the Medical Device Regulation (MDR) framework. It is classified as a Class II medical device under FDA regulations and was reviewed by the Cardiovascular (CV) Advisory Committee.
How should the VersaCross Connect Transseptal Dilator be stored before use?
While the device is supplied non-sterile, it must be used in sterile environments. Storage instructions are not explicitly detailed in the provided data, but standard medical device handling guidelines should be followed to maintain functionality and sterility before use.
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.
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 | K251325 | Class II | Active |
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Manufacturer
- Manufacturer
- Baylis Medical Company Inc.
- FDA Applicant
- Baylis Medical Company, Inc.
Sources (2)
- FDA 510(k) K251325 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026