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FDA 510(k)

VACU-MED BLOOD COLLECTION NEEDLES

K-Number: K071947 · 2007-10-12

ApplicantShina Corp.
Decision Date2007-10-12
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VACU-MED BLOOD COLLECTION NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Shina Corp.. It received FDA 510(k) clearance on 2007-10-12 under 510(k) number K071947. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACU-MED BLOOD COLLECTION NEEDLES?

VACU-MED BLOOD COLLECTION NEEDLES is a medical device that received FDA 510(k) clearance on 2007-10-12. The listed applicant is Shina Corp.. The 510(k) number is K071947.

When did VACU-MED BLOOD COLLECTION NEEDLES receive FDA 510(k) clearance?

VACU-MED BLOOD COLLECTION NEEDLES received FDA 510(k) clearance on 2007-10-12, under 510(k) number K071947.

Who is the listed applicant for VACU-MED BLOOD COLLECTION NEEDLES?

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

What is the FDA product code for VACU-MED BLOOD COLLECTION NEEDLES?

The FDA product code for VACU-MED BLOOD COLLECTION NEEDLES is FMI.

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Other records listing Shina Corp. 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.

K113186STERILE INSULIN PEN NEEDLEK091167SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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.

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