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FDA 510(k)

NEW-VENT

K-Number: K911809 · 1991-08-26

ApplicantConcord/Portex
Decision Date1991-08-26
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEW-VENT is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K911809. 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 NEW-VENT?

NEW-VENT is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Concord/Portex. The 510(k) number is K911809.

When did NEW-VENT receive FDA 510(k) clearance?

NEW-VENT received FDA 510(k) clearance on 1991-08-26, under 510(k) number K911809.

Who is the listed applicant for NEW-VENT?

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

What is the FDA product code for NEW-VENT?

The FDA product code for NEW-VENT is JKA.

Other records listing Concord/Portex 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.

K923559STERI-CATH MDIK930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESK924541EPIDURAL MINIPACKK930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITSK923127NEEDLE-PRO CARTRIDGEK923910HEAT MOISTURE CONDENSER

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Related Devices (Code: JKA)

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.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.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 CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

Official Source

View on FDA Database →

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

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