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FDA 510(k)

CORONARY GUIDE WIRE

K-Number: K883579 · 1988-11-04

ApplicantDatascope Corp.
Decision Date1988-11-04
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORONARY GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1988-11-04 under 510(k) number K883579. 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 CORONARY GUIDE WIRE?

CORONARY GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is Datascope Corp.. The 510(k) number is K883579.

When did CORONARY GUIDE WIRE receive FDA 510(k) clearance?

CORONARY GUIDE WIRE received FDA 510(k) clearance on 1988-11-04, under 510(k) number K883579.

Who is the listed applicant for CORONARY GUIDE WIRE?

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

What is the FDA product code for CORONARY GUIDE WIRE?

The FDA product code for CORONARY GUIDE WIRE is DQX.

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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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