FDA 510(k)

CardioCurve Steerable Sheath

Numéro K : K210185 · 2021-07-23

Date de décision2021-07-23

Code produitDYB

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

CardioCurve Steerable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Talon Surgical. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K210185. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CardioCurve Steerable Sheath?

CardioCurve Steerable Sheath is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Talon Surgical. The 510(k) number is K210185.

When did CardioCurve Steerable Sheath receive FDA 510(k) clearance?

CardioCurve Steerable Sheath received FDA 510(k) clearance on 2021-07-23, under 510(k) number K210185.

Who is the listed applicant for CardioCurve Steerable Sheath?

The FDA 510(k) record lists Talon Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioCurve Steerable Sheath?

The FDA product code for CardioCurve Steerable Sheath is DYB.

Essais cliniques associés

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Dispositifs connexes (Code : 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

Source officielle

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