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FDA 510(k)

ACCU-VENT(TM) WITH NEEDLE-PRO(TM)

K-Number: K912043 · 1991-07-05

ApplicantConcord/Portex
Decision Date1991-07-05
Product CodeCBT
Advisory CommitteeAN
DecisionUnknown

Device Summary

ACCU-VENT(TM) WITH NEEDLE-PRO(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1991-07-05 under 510(k) number K912043. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ACCU-VENT(TM) WITH NEEDLE-PRO(TM)?

ACCU-VENT(TM) WITH NEEDLE-PRO(TM) is a medical device that received FDA 510(k) clearance on 1991-07-05. The listed applicant is Concord/Portex. The 510(k) number is K912043.

When did ACCU-VENT(TM) WITH NEEDLE-PRO(TM) receive FDA 510(k) clearance?

ACCU-VENT(TM) WITH NEEDLE-PRO(TM) received FDA 510(k) clearance on 1991-07-05, under 510(k) number K912043.

Who is the listed applicant for ACCU-VENT(TM) WITH NEEDLE-PRO(TM)?

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 ACCU-VENT(TM) WITH NEEDLE-PRO(TM)?

The FDA product code for ACCU-VENT(TM) WITH NEEDLE-PRO(TM) is CBT.

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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

View all 23 devices →

Related Devices (Code: CBT)

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.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K950098NEEDLE SAFETY COVERHammer-Plane, Inc.

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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