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FDA 510(k)

INTRAVASCULAR IMAGING SYSTEM

K-Number: K895159 · 1990-03-12

ApplicantIntertherapy, Inc.
Decision Date1990-03-12
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTRAVASCULAR IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intertherapy, Inc.. It received FDA 510(k) clearance on 1990-03-12 under 510(k) number K895159. 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 INTRAVASCULAR IMAGING SYSTEM?

INTRAVASCULAR IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-12. The listed applicant is Intertherapy, Inc.. The 510(k) number is K895159.

When did INTRAVASCULAR IMAGING SYSTEM receive FDA 510(k) clearance?

INTRAVASCULAR IMAGING SYSTEM received FDA 510(k) clearance on 1990-03-12, under 510(k) number K895159.

Who is the listed applicant for INTRAVASCULAR IMAGING SYSTEM?

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 INTRAVASCULAR IMAGING SYSTEM?

The FDA product code for INTRAVASCULAR IMAGING SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K913763INTERPRET(TM) CATHETER LINEAR TRANSLATORK912600INTERPRET(TM) INTRAVASCULAR IMAGING CATHETERK910281INTRAVASCULAR IMAGING SYSTEM/MODIFIEDK900305INTRAVASCULAR IMAGING SYSTEMS

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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