FDA 510(k)

Nanostim Introducer Kit

Número K: K161102 · 2016-05-19

Data da decisão2016-05-19

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nanostim Introducer Kit is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K161102. 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 Nanostim Introducer Kit?

Nanostim Introducer Kit is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K161102.

When did Nanostim Introducer Kit receive FDA 510(k) clearance?

Nanostim Introducer Kit received FDA 510(k) clearance on 2016-05-19, under 510(k) number K161102.

Who is the listed applicant for Nanostim Introducer Kit?

The FDA 510(k) record lists St. Jude Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nanostim Introducer Kit?

The FDA product code for Nanostim Introducer Kit is DYB.

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Outros registros que listam St. Jude Medical, Inc. como candidato(a)

K172393Cáteter de Mapeamento de Grade HD Advisor, com Sensor Habilitado K163407Confirm Rx Insertable Cardiac Monitor (ICM) System K161171PressureWire X Guidewire K160716The Nanostim Introducer Kit

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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