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FDA 510(k)

SafeCross Transseptal Puncture and Introducer (TSP/I) System

K-Number: K203459 · 2021-07-06

ApplicantEast End Medical I, LLC
Decision Date2021-07-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeCross Transseptal Puncture and Introducer (TSP/I) System is the device name listed in this FDA 510(k) record. The listed applicant is East End Medical I, LLC. It received FDA 510(k) clearance on 2021-07-06 under 510(k) number K203459. 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 Transseptal Puncture and Introducer (TSP/I) System?

SafeCross Transseptal Puncture and Introducer (TSP/I) System is a medical device that received FDA 510(k) clearance on 2021-07-06. The listed applicant is East End Medical I, LLC. The 510(k) number is K203459.

When did SafeCross Transseptal Puncture and Introducer (TSP/I) System receive FDA 510(k) clearance?

SafeCross Transseptal Puncture and Introducer (TSP/I) System received FDA 510(k) clearance on 2021-07-06, under 510(k) number K203459.

Who is the listed applicant for SafeCross Transseptal Puncture and Introducer (TSP/I) System?

The FDA 510(k) record lists East End Medical I, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeCross Transseptal Puncture and Introducer (TSP/I) System?

The FDA product code for SafeCross Transseptal Puncture and Introducer (TSP/I) System is DYB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07515040Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- GuidanceRECRUITING

Other records listing East End Medical I, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240600SafeCross Vascular Introducer System (4001)

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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