FDA 510(k)

CHIRAVAC Blood Collection Needles

K-Number: K201009 · 2021-07-21

Decision Date2021-07-21

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CHIRAVAC Blood Collection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T. Injecta. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K201009. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHIRAVAC Blood Collection Needles?

CHIRAVAC Blood Collection Needles is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Chirana T. Injecta. The 510(k) number is K201009.

When did CHIRAVAC Blood Collection Needles receive FDA 510(k) clearance?

CHIRAVAC Blood Collection Needles received FDA 510(k) clearance on 2021-07-21, under 510(k) number K201009.

Who is the listed applicant for CHIRAVAC Blood Collection Needles?

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

What is the FDA product code for CHIRAVAC Blood Collection Needles?

The FDA product code for CHIRAVAC Blood Collection Needles is JKA.

Other records listing Chirana T. Injecta as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242434Insulin Syringes K220614MEDOJECT fine Pen Needles K201044CHIRANA Insulin Syringes

Related Devices (Code: JKA)

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.