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FDA 510(k)

TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)

K-Number: K090973 · 2009-05-01

ApplicantTerumo Corp.
Decision Date2009-05-01
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K090973. 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 SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)?

TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Terumo Corp.. The 510(k) number is K090973.

When did TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) receive FDA 510(k) clearance?

TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) received FDA 510(k) clearance on 2009-05-01, under 510(k) number K090973.

Who is the listed applicant for TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)?

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

What is the FDA product code for TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)?

The FDA product code for TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) is FOZ.

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Other records listing Terumo Corp. 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.

K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERK092372HEARTRAIL III GUIDING CATHETERK091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527AK073474CAPIOX CIRCUIT CONNECTORSK071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTERK071494CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER

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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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