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FDA 510(k)

GUIDE WIRE INTRODUCER

K-Number: K890807 · 1989-06-20

ApplicantDatascope Corp.
Decision Date1989-06-20
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDE WIRE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K890807. 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 WIRE INTRODUCER?

GUIDE WIRE INTRODUCER is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Datascope Corp.. The 510(k) number is K890807.

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

GUIDE WIRE INTRODUCER received FDA 510(k) clearance on 1989-06-20, under 510(k) number K890807.

Who is the listed applicant for GUIDE WIRE INTRODUCER?

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 GUIDE WIRE INTRODUCER?

The FDA product code for GUIDE WIRE INTRODUCER 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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