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SafeCross Transseptal Puncture and Introducer System

by East End Medical I, LLC

510(k) K203459

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203459 Date6 Jul 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
SafeCross Transseptal Puncture and Introducer (TSP/I) System
510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SafeCross Transseptal Puncture and Introducer System is a medical device designed for transseptal puncture procedures. It functions as an integrated system to facilitate access during cardiovascular interventions.

This device is supplied for clinical use and has received FDA 510k clearance. It is identified by the product code DYB and is categorized under the cardiovascular advisory committee.

Other devices from East End Medical I, LLC

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the SafeCross Transseptal Puncture and Introducer System?

    The SafeCross Transseptal Puncture and Introducer System is designed specifically to perform transseptal puncture procedures. It functions as an integrated system to provide necessary access for clinicians during cardiovascular interventions.

  • What is the regulatory status of this device?

    The SafeCross Transseptal Puncture and Introducer System has received FDA 510k clearance. It is identified under the cardiovascular advisory committee and is classified by product code DYB.

  • Who is the manufacturer of the SafeCross Transseptal Puncture and Introducer System?

    The device is manufactured by East End Medical I, LLC, which is based in Sunrise, Florida. The system was submitted for regulatory review under K-number K203459.