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FDA 510(k)

FOUNDATION

K-Number: K040783 · 2004-10-13

ApplicantTerumo Corp.
Decision Date2004-10-13
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FOUNDATION is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 2004-10-13 under 510(k) number K040783. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOUNDATION?

FOUNDATION is a medical device that received FDA 510(k) clearance on 2004-10-13. The listed applicant is Terumo Corp.. The 510(k) number is K040783.

When did FOUNDATION receive FDA 510(k) clearance?

FOUNDATION received FDA 510(k) clearance on 2004-10-13, under 510(k) number K040783.

Who is the listed applicant for FOUNDATION?

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 FOUNDATION?

The FDA product code for FOUNDATION is LYC.

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Related PubMed Literature

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PMID: 34478784Foundational Considerations for Artificial Intelligence Using Ophthalmic Images.Ophthalmology ()

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-240-3527AK090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)K073474CAPIOX CIRCUIT CONNECTORSK071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

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Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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