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FDA 510(k)

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01

K-Number: K050808 · 2005-07-28

ApplicantCardio-Optics, Inc.
Decision Date2005-07-28
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 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 2005-07-28 under 510(k) number K050808. 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 CORONARY SINUS ACCESS KIT, MODEL KCS8F-01?

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 is a medical device that received FDA 510(k) clearance on 2005-07-28. The listed applicant is Cardio-Optics, Inc.. The 510(k) number is K050808.

When did CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 receive FDA 510(k) clearance?

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 received FDA 510(k) clearance on 2005-07-28, under 510(k) number K050808.

Who is the listed applicant for CORONARY SINUS ACCESS KIT, MODEL KCS8F-01?

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 CORONARY SINUS ACCESS KIT, MODEL KCS8F-01?

The FDA product code for CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 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.

K062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL 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.K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, Inc.K001408KSEA VASCULAR FIBERSCOPESKARL STORZ Endoscopy-America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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