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FDA 510(k)

CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM

K-Number: K062340 · 2006-11-30

ApplicantCardio-Optics, Inc.
Decision Date2006-11-30
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Optics, Inc.. It received FDA 510(k) clearance on 2006-11-30 under 510(k) number K062340. 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 CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM?

CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-11-30. The listed applicant is Cardio-Optics, Inc.. The 510(k) number is K062340.

When did CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM receive FDA 510(k) clearance?

CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM received FDA 510(k) clearance on 2006-11-30, under 510(k) number K062340.

Who is the listed applicant for CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM?

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

What is the FDA product code for CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM?

The FDA product code for CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL 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.

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Other records listing Cardio-Optics, 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.

K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01

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 CorpK050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, Inc.K001408KSEA VASCULAR FIBERSCOPESKARL STORZ Endoscopy-America, 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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