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FDA 510(k)

MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER

K-Number: K954457 · 1996-05-15

ApplicantMedi-Tech, Inc.
Decision Date1996-05-15
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER 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 1996-05-15 under 510(k) number K954457. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER?

MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1996-05-15. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K954457.

When did MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER receive FDA 510(k) clearance?

MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER received FDA 510(k) clearance on 1996-05-15, under 510(k) number K954457.

Who is the listed applicant for MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER?

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 MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER?

The FDA product code for MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER is KRA.

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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.

K952345MEDI-TECH PLATFORM GUIDE CATHETERK952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLSK922990HEMODIALYSIS BATH

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Related Devices (Code: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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