FDA 510(k)

PIVO™ Pro Needle-free Blood Collection Device

Numéro K : K230865 · 2023-09-28

DemandeurBecton Dickinson Infusion Therapy Systems, Inc.

Date de décision2023-09-28

Code produitJKA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

PIVO™ Pro Needle-free Blood Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2023-09-28 under 510(k) number K230865. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the PIVO™ Pro Needle-free Blood Collection Device?

PIVO™ Pro Needle-free Blood Collection Device is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K230865.

When did PIVO™ Pro Needle-free Blood Collection Device receive FDA 510(k) clearance?

PIVO™ Pro Needle-free Blood Collection Device received FDA 510(k) clearance on 2023-09-28, under 510(k) number K230865.

Who is the listed applicant for PIVO™ Pro Needle-free Blood Collection Device?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIVO™ Pro Needle-free Blood Collection Device?

The FDA product code for PIVO™ Pro Needle-free Blood Collection Device is JKA.

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Source officielle

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