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FDA 510(k)

TERUMO SURFLASH SAFETY I.V. CATHETER

K-Number: K122544 · 2012-09-05

ApplicantTerumo Corporation
Decision Date2012-09-05
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUMO SURFLASH SAFETY I.V. CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2012-09-05 under 510(k) number K122544. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO SURFLASH SAFETY I.V. CATHETER?

TERUMO SURFLASH SAFETY I.V. CATHETER is a medical device that received FDA 510(k) clearance on 2012-09-05. The listed applicant is Terumo Corporation. The 510(k) number is K122544.

When did TERUMO SURFLASH SAFETY I.V. CATHETER receive FDA 510(k) clearance?

TERUMO SURFLASH SAFETY I.V. CATHETER received FDA 510(k) clearance on 2012-09-05, under 510(k) number K122544.

Who is the listed applicant for TERUMO SURFLASH SAFETY I.V. CATHETER?

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

What is the FDA product code for TERUMO SURFLASH SAFETY I.V. CATHETER?

The FDA product code for TERUMO SURFLASH SAFETY I.V. CATHETER is FOZ.

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 Terumo Corporation 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.

K252295RyureiK250700Pen Injector Needle 32.5K250751DualView CatheterK240818R2P Radifocus Glidewire AdvantageK240859Glidewire GT-RK190427Immucise

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Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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