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FDA 510(k)

MEDI-TECH PLATFORM GUIDE CATHETER

K-Number: K952345 · 1995-08-17

ApplicantMedi-Tech, Inc.
Decision Date1995-08-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-TECH PLATFORM GUIDE 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 1995-08-17 under 510(k) number K952345. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-TECH PLATFORM GUIDE CATHETER?

MEDI-TECH PLATFORM GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 1995-08-17. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K952345.

When did MEDI-TECH PLATFORM GUIDE CATHETER receive FDA 510(k) clearance?

MEDI-TECH PLATFORM GUIDE CATHETER received FDA 510(k) clearance on 1995-08-17, under 510(k) number K952345.

Who is the listed applicant for MEDI-TECH PLATFORM GUIDE 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 PLATFORM GUIDE CATHETER?

The FDA product code for MEDI-TECH PLATFORM GUIDE CATHETER is DQY.

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

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Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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