FDA 510(k)

SafeCross Transseptal Puncture and Introducer (TSP/I) System

Número K: K203459 · 2021-07-06

Data da decisão2021-07-06

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam East End Medical I, LLC como candidato(a)

K240600SafeCross Vascular Introducer System (4001)

Dispositivos Relacionados (Código: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture 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, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

Fonte oficial

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