Cleared Special

VersaCross Connect? Transseptal Dilator

K251325 · Baylis Medical Company, Inc. · Cardiovascular
May 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K251325 is an FDA 510(k) clearance for the VersaCross Connect? Transseptal Dilator, a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on May 29, 2025, 30 days after receiving the submission on April 29, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K251325 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2025
Decision Date May 29, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRE — Dilator, Vessel, For Percutaneous Catheterization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1310

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