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FDA 510(k)

SafeCross Vascular Introducer System (4001)

K-Number: K240600 · 2024-09-06

ApplicantEast End Medical I, LLC
Decision Date2024-09-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeCross Vascular Introducer System (4001) is a medical device manufactured by East End Medical I, LLC. It received FDA 510(k) clearance on 2024-09-06 under approval number K240600. 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 SafeCross Vascular Introducer System (4001)?

SafeCross Vascular Introducer System (4001) is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by East End Medical I, LLC. The 510(k) number is K240600.

When was SafeCross Vascular Introducer System (4001) approved by the FDA?

SafeCross Vascular Introducer System (4001) received FDA 510(k) clearance on 2024-09-06, under approval number K240600.

What company makes SafeCross Vascular Introducer System (4001)?

SafeCross Vascular Introducer System (4001) is manufactured by East End Medical I, LLC.

What is the FDA product code for SafeCross Vascular Introducer System (4001)?

The FDA product code for SafeCross Vascular Introducer System (4001) is DYB.

Related Clinical Trials

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Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024)

Other Devices by East End Medical I, LLC

K203459SafeCross Transseptal Puncture and Introducer (TSP/I) System

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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.

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