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)

ExpanSure Large Access Transseptal Dilator

K-Number: K201288 · 2020-06-12

ApplicantBaylis Medical Company, Inc.
Decision Date2020-06-12
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ExpanSure Large Access Transseptal Dilator is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2020-06-12 under approval number K201288. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ExpanSure Large Access Transseptal Dilator?

ExpanSure Large Access Transseptal Dilator is a medical device that received FDA 510(k) clearance on 2020-06-12. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K201288.

When was ExpanSure Large Access Transseptal Dilator approved by the FDA?

ExpanSure Large Access Transseptal Dilator received FDA 510(k) clearance on 2020-06-12, under approval number K201288.

What company makes ExpanSure Large Access Transseptal Dilator?

ExpanSure Large Access Transseptal Dilator is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for ExpanSure Large Access Transseptal Dilator?

The FDA product code for ExpanSure Large Access Transseptal Dilator is DRE.

Related Clinical Trials

NCT02603640 " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy COMPLETED NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT07541235 The Ladera Suture-Mediated Large Bore Closure Pivotal Study NOT_YET_RECRUITING NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING NCT06837870 Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation. ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 39881617 Arthroplasty registries at a glance: an initiative of the International Society of Arthroplasty Registries (ISAR) to facilitate access, understanding, and reporting of registry data from an international perspective. Acta orthopaedica (2025)

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: DRE)

K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc. K150932Sheath IntroducerBioteque Corp. K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. K162389Medcomp Vessel DilatorMedcomp ( Medical Components) K170616van Andel Dilatation CatheterCook Incorporated

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.

↑