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FDA 510(k)

GUIDE WIRES, MODIFICATION

K-Number: K914986 · 1992-05-20

ApplicantE-Z-Em, Inc.
Decision Date1992-05-20
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDE WIRES, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1992-05-20 under 510(k) number K914986. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDE WIRES, MODIFICATION?

GUIDE WIRES, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-05-20. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K914986.

When did GUIDE WIRES, MODIFICATION receive FDA 510(k) clearance?

GUIDE WIRES, MODIFICATION received FDA 510(k) clearance on 1992-05-20, under 510(k) number K914986.

Who is the listed applicant for GUIDE WIRES, MODIFICATION?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUIDE WIRES, MODIFICATION?

The FDA product code for GUIDE WIRES, MODIFICATION is DQX.

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Other records listing E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD 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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