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FDA 510(k)

VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)

K-Number: K861449 · 1986-09-16

ApplicantExel Intl.
Decision Date1986-09-16
Product CodeGIM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) is the device name listed in this FDA 510(k) record. The listed applicant is Exel Intl.. It received FDA 510(k) clearance on 1986-09-16 under 510(k) number K861449. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)?

VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) is a medical device that received FDA 510(k) clearance on 1986-09-16. The listed applicant is Exel Intl.. The 510(k) number is K861449.

When did VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) receive FDA 510(k) clearance?

VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) received FDA 510(k) clearance on 1986-09-16, under 510(k) number K861449.

Who is the listed applicant for VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)?

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

What is the FDA product code for VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)?

The FDA product code for VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) is GIM.

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Other records listing Exel Intl. 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.

K992290EXEL INJECTION PLUG WITH CAPK963658EXEL AVF SINGLE NEEDLEK963659EXEL I.V. ADMINISTRATION SETK926119EXEL HUBER INFUSION SET ROTATING WINGK904685EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)K903945EXEL A-V FISTULA SET

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Related Devices (Code: GIM)

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.

K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and CompanyK230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and CompanyK213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesBecton, Dickinson and CompanyK162723TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd.K080552CYTO-CHEX BCTStreckK012152DS30 HCY BLOOD COLLECTION TUBESDrew Scientific , Ltd.

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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