FDA 510(k)

The CVC WAND Safety Introducer with Valved Peelable Sheath

N.º K: K182243 · 2018-09-18

Fecha de decisión2018-09-18

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

The CVC WAND Safety Introducer with Valved Peelable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Access Scientific, LLC. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K182243. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the The CVC WAND Safety Introducer with Valved Peelable Sheath?

The CVC WAND Safety Introducer with Valved Peelable Sheath is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Access Scientific, LLC. The 510(k) number is K182243.

When did The CVC WAND Safety Introducer with Valved Peelable Sheath receive FDA 510(k) clearance?

The CVC WAND Safety Introducer with Valved Peelable Sheath received FDA 510(k) clearance on 2018-09-18, under 510(k) number K182243.

Who is the listed applicant for The CVC WAND Safety Introducer with Valved Peelable Sheath?

The FDA 510(k) record lists Access Scientific, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The CVC WAND Safety Introducer with Valved Peelable Sheath?

The FDA product code for The CVC WAND Safety Introducer with Valved Peelable Sheath is DYB.

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Otros registros que enlistan a Access Scientific, LLC como solicitante

K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

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

Fuente oficial

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