FDA 510(k)

Bendit2.7 Steerable Microcatheter

N.º K: K190126 · 2019-08-22

Fecha de decisión2019-08-22

Código de productoDQO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Bendit2.7 Steerable Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Bend IT Technologies, Ltd.. It received FDA 510(k) clearance on 2019-08-22 under 510(k) number K190126. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bendit2.7 Steerable Microcatheter?

Bendit2.7 Steerable Microcatheter is a medical device that received FDA 510(k) clearance on 2019-08-22. The listed applicant is Bend IT Technologies, Ltd.. The 510(k) number is K190126.

When did Bendit2.7 Steerable Microcatheter receive FDA 510(k) clearance?

Bendit2.7 Steerable Microcatheter received FDA 510(k) clearance on 2019-08-22, under 510(k) number K190126.

Who is the listed applicant for Bendit2.7 Steerable Microcatheter?

The FDA 510(k) record lists Bend IT Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bendit2.7 Steerable Microcatheter?

The FDA product code for Bendit2.7 Steerable Microcatheter is DQO.

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Otros registros que enlistan a Bend IT Technologies, Ltd. como solicitante

K252213Bendit17 Microcatheter K203842Bendit21 Microcatheter K200582Bendit2.7 Steerable Microcatheter

Dispositivos relacionados (Código: DQO)

K261455Conjunto/Plato de Monitoreo de Presión ArterialSpectrum Vascular K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Conjunto/Plato de Monitoreo de Presión ArterialSpectrum Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Fuente oficial

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