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FDA 510(k)

INTERPRET(TM) CATHETER LINEAR TRANSLATOR

K-Number: K913763 · 1991-11-20

ApplicantIntertherapy, Inc.
Decision Date1991-11-20
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTERPRET(TM) CATHETER LINEAR TRANSLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Intertherapy, Inc.. It received FDA 510(k) clearance on 1991-11-20 under 510(k) number K913763. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERPRET(TM) CATHETER LINEAR TRANSLATOR?

INTERPRET(TM) CATHETER LINEAR TRANSLATOR is a medical device that received FDA 510(k) clearance on 1991-11-20. The listed applicant is Intertherapy, Inc.. The 510(k) number is K913763.

When did INTERPRET(TM) CATHETER LINEAR TRANSLATOR receive FDA 510(k) clearance?

INTERPRET(TM) CATHETER LINEAR TRANSLATOR received FDA 510(k) clearance on 1991-11-20, under 510(k) number K913763.

Who is the listed applicant for INTERPRET(TM) CATHETER LINEAR TRANSLATOR?

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

What is the FDA product code for INTERPRET(TM) CATHETER LINEAR TRANSLATOR?

The FDA product code for INTERPRET(TM) CATHETER LINEAR TRANSLATOR is LYK.

Related Clinical Trials

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.

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Other records listing Intertherapy, 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.

K912600INTERPRET(TM) INTRAVASCULAR IMAGING CATHETERK910281INTRAVASCULAR IMAGING SYSTEM/MODIFIEDK900305INTRAVASCULAR IMAGING SYSTEMSK895159INTRAVASCULAR IMAGING SYSTEM

Related Devices (Code: LYK)

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.

K253842Vena MicroAngioscope™ SystemVena Medical Holdings CorpK251767Vena MicroAngioscope™ SystemVena Medical Holdings CorpK062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCardio-Optics, Inc.K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, Inc.

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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