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FDA 510(k)

Safety Blood Collection Set

K-Number: K163093 · 2017-03-14

ApplicantJiangsu Shenli Medical Production Co., Ltd.
Decision Date2017-03-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K163093. 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 Safety Blood Collection Set?

Safety Blood Collection Set is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. The 510(k) number is K163093.

When did Safety Blood Collection Set receive FDA 510(k) clearance?

Safety Blood Collection Set received FDA 510(k) clearance on 2017-03-14, under 510(k) number K163093.

Who is the listed applicant for Safety Blood Collection Set?

The FDA 510(k) record lists Jiangsu Shenli Medical Production Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Blood Collection Set?

The FDA product code for Safety Blood Collection Set is FMI.

Other records listing Jiangsu Shenli Medical Production Co., Ltd. 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.

K200557Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)K180259Sterile Hypodermic Needle for Single Use

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.

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.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., 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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