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FDA 510(k)

EXTRESAFE PHLEBOTOMY

K-Number: K964042 · 1997-06-06

ApplicantSpecialized Health Products, Inc.
Decision Date1997-06-06
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXTRESAFE PHLEBOTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Specialized Health Products, Inc.. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K964042. 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 EXTRESAFE PHLEBOTOMY?

EXTRESAFE PHLEBOTOMY is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Specialized Health Products, Inc.. The 510(k) number is K964042.

When did EXTRESAFE PHLEBOTOMY receive FDA 510(k) clearance?

EXTRESAFE PHLEBOTOMY received FDA 510(k) clearance on 1997-06-06, under 510(k) number K964042.

Who is the listed applicant for EXTRESAFE PHLEBOTOMY?

The FDA 510(k) record lists Specialized Health Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTRESAFE PHLEBOTOMY?

The FDA product code for EXTRESAFE PHLEBOTOMY 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 Specialized Health Products, 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.

K050023SECURELOC; ADVANCINTRODUCERK013394LIFTLOC SAFETY INFUSION SETK962149SAFETY CRADLE

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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