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FDA 510(k)

KATZEN THROMBOLYSIS GUIDEWIRE

K-Number: K883880 · 1989-04-06

ApplicantMedi-Tech, Inc.
Decision Date1989-04-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KATZEN THROMBOLYSIS GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1989-04-06 under 510(k) number K883880. 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 KATZEN THROMBOLYSIS GUIDEWIRE?

KATZEN THROMBOLYSIS GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1989-04-06. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K883880.

When did KATZEN THROMBOLYSIS GUIDEWIRE receive FDA 510(k) clearance?

KATZEN THROMBOLYSIS GUIDEWIRE received FDA 510(k) clearance on 1989-04-06, under 510(k) number K883880.

Who is the listed applicant for KATZEN THROMBOLYSIS GUIDEWIRE?

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

What is the FDA product code for KATZEN THROMBOLYSIS GUIDEWIRE?

The FDA product code for KATZEN THROMBOLYSIS GUIDEWIRE is DQX.

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Other records listing Medi-Tech, 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.

K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERK952345MEDI-TECH PLATFORM GUIDE CATHETERK952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLS

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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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