Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VersaCross Steerable Sheath, VersaCross Transseptal Dilator

K-Number: K190688 · 2019-04-17

ApplicantBaylis Medical Company, Inc.
Decision Date2019-04-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VersaCross Steerable Sheath, VersaCross Transseptal Dilator is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-04-17 under approval number K190688. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VersaCross Steerable Sheath, VersaCross Transseptal Dilator?

VersaCross Steerable Sheath, VersaCross Transseptal Dilator is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K190688.

When was VersaCross Steerable Sheath, VersaCross Transseptal Dilator approved by the FDA?

VersaCross Steerable Sheath, VersaCross Transseptal Dilator received FDA 510(k) clearance on 2019-04-17, under approval number K190688.

What company makes VersaCross Steerable Sheath, VersaCross Transseptal Dilator?

VersaCross Steerable Sheath, VersaCross Transseptal Dilator is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for VersaCross Steerable Sheath, VersaCross Transseptal Dilator?

The FDA product code for VersaCross Steerable Sheath, VersaCross Transseptal Dilator is DYB.

Other Devices by Baylis Medical Company, Inc.

K161878PORTAGE System K161949OsteoCool V-3 RF Ablation System K191546Epicardial Access System K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable K183649Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable K183655VersaCross Transseptal Sheath

View all 18 devices →

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162097InTRAkitMedtronic Vascular K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑