Cleared Special

VersaCross Connect? Transseptal Dilator

K241720 · Baylis Medical Company, Inc. · Cardiovascular
Jul 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K241720 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 July 12, 2024, 28 days after receiving the submission on June 14, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K241720 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2024
Decision Date July 12, 2024
Days to Decision 28 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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