Cleared Special

VersaCross Connect? Transseptal Dilator

K233647 · Baylis Medical Company, Inc. · Cardiovascular
Dec 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K233647 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 December 14, 2023, 30 days after receiving the submission on November 14, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K233647 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2023
Decision Date December 14, 2023
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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