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FDA 510(k)

PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE

K-Number: K895024 · 1990-09-21

ApplicantBio-Plexus, Inc.
Decision Date1990-09-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Plexus, Inc.. It received FDA 510(k) clearance on 1990-09-21 under 510(k) number K895024. 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 PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE?

PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE is a medical device that received FDA 510(k) clearance on 1990-09-21. The listed applicant is Bio-Plexus, Inc.. The 510(k) number is K895024.

When did PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE receive FDA 510(k) clearance?

PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE received FDA 510(k) clearance on 1990-09-21, under 510(k) number K895024.

Who is the listed applicant for PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE?

The FDA 510(k) record lists Bio-Plexus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE?

The FDA product code for PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE is FMI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bio-Plexus, Inc. 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.

K003827PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTIONK992091PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750K963748BIO-PLEXUS DROP-IT NEEDLE HOLDERK960933BIO-PLEXUS NEEDLE DISPOSAL CONTAINERK961251PUNCTUR-GUARD WINGED SET

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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