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FDA 510(k)

CATHETER, TRANSLUMINAL BALLOON

K-Number: K781772 · 1979-03-06

ApplicantMedi-Tech, Inc.
Decision Date1979-03-06
Product CodeGBA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CATHETER, TRANSLUMINAL BALLOON 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 1979-03-06 under 510(k) number K781772. The device is classified under product code GBA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, TRANSLUMINAL BALLOON?

CATHETER, TRANSLUMINAL BALLOON is a medical device that received FDA 510(k) clearance on 1979-03-06. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K781772.

When did CATHETER, TRANSLUMINAL BALLOON receive FDA 510(k) clearance?

CATHETER, TRANSLUMINAL BALLOON received FDA 510(k) clearance on 1979-03-06, under 510(k) number K781772.

Who is the listed applicant for CATHETER, TRANSLUMINAL BALLOON?

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 CATHETER, TRANSLUMINAL BALLOON?

The FDA product code for CATHETER, TRANSLUMINAL BALLOON is GBA.

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Other records listing Medi-Tech, Inc. as applicant

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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: GBA)

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.

K861877BYRON WORD BARTHOLIAN GLAND CATHETERByron MedicalK802025BALLOON RETENTION CHEST CATHETERLoseff Medical Designers, Ltd.K790444ELECATH MULTI-PURPOSE ARTERIAL SURGERElectro-Catheter Corp.K781665TUBE, LEATHERMAN/IMBRUCENational Catheter Co. Div. Mallinckrodt

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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