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FDA 510(k)

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

K-Number: K100282 · 2010-02-26

ApplicantTerumo Corp.
Decision Date2010-02-26
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 2010-02-26 under 510(k) number K100282. 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- PUR SAFETY I.V. CATHETER?

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER is a medical device that received FDA 510(k) clearance on 2010-02-26. The listed applicant is Terumo Corp.. The 510(k) number is K100282.

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

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER received FDA 510(k) clearance on 2010-02-26, under 510(k) number K100282.

Who is the listed applicant for TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER?

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- PUR SAFETY I.V. CATHETER?

The FDA product code for TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER 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.

K092372HEARTRAIL 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-240-3527AK090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)K073474CAPIOX 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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