FDA 510(k)

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

Numéro K : K241042 · 2024-05-17

DemandeurPressure Products Medical Device Manufacturing, LLC

Date de décision2024-05-17

Code produitDRC

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is the device name listed in this FDA 510(k) record. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2024-05-17 under 510(k) number K241042. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K241042.

When did SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) receive FDA 510(k) clearance?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) received FDA 510(k) clearance on 2024-05-17, under 510(k) number K241042.

Who is the listed applicant for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

The FDA 510(k) record lists Pressure Products Medical Device Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

The FDA product code for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is DRC.

Essais cliniques associés

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Dispositifs connexes (Code : DRC)

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Source officielle

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