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FDA 510(k)

PROGUARDII(TM) BLOOD COLLECTION DEVICE

K-Number: K913914 · 1991-10-08

ApplicantCare Medical Devices, Inc.
Decision Date1991-10-08
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROGUARDII(TM) BLOOD COLLECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Care Medical Devices, Inc.. It received FDA 510(k) clearance on 1991-10-08 under 510(k) number K913914. 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 PROGUARDII(TM) BLOOD COLLECTION DEVICE?

PROGUARDII(TM) BLOOD COLLECTION DEVICE is a medical device that received FDA 510(k) clearance on 1991-10-08. The listed applicant is Care Medical Devices, Inc.. The 510(k) number is K913914.

When did PROGUARDII(TM) BLOOD COLLECTION DEVICE receive FDA 510(k) clearance?

PROGUARDII(TM) BLOOD COLLECTION DEVICE received FDA 510(k) clearance on 1991-10-08, under 510(k) number K913914.

Who is the listed applicant for PROGUARDII(TM) BLOOD COLLECTION DEVICE?

The FDA 510(k) record lists Care Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROGUARDII(TM) BLOOD COLLECTION DEVICE?

The FDA product code for PROGUARDII(TM) BLOOD COLLECTION DEVICE 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.

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Other records listing Care Medical Devices, 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.

K932789ONE-SITE IV CONNECTOR

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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