FDA 510(k)

VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)

K-Number: K971449 · 1997-06-17

ApplicantBecton Dickinson Vacutainer Systems

Decision Date1997-06-17

Product CodeGIM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Vacutainer Systems. It received FDA 510(k) clearance on 1997-06-17 under 510(k) number K971449. 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 VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)?

VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Becton Dickinson Vacutainer Systems. The 510(k) number is K971449.

When did VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) receive FDA 510(k) clearance?

VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) received FDA 510(k) clearance on 1997-06-17, under 510(k) number K971449.

Who is the listed applicant for VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)?

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

What is the FDA product code for VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)?

The FDA product code for VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) is GIM.

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Other records listing Becton Dickinson Vacutainer Systems as applicant

K002456MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 K991702MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE K991120VACUTAINER BRAND CTAD TUBE (MULTIPLE)K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 K982922VACUTAINER BRAND BLOOD COLLECTION SYRINGE

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Related Devices (Code: GIM)

K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and Company K230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and Company K213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesBecton, Dickinson and Company K162723TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd.K080552CYTO-CHEX BCTStreck K012152DS30 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.