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FDA 510(k)

APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE

K-Number: K951721 · 1995-07-11

ApplicantApplied Medical Resources
Decision Date1995-07-11
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K951721. 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 APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE?

APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is Applied Medical Resources. The 510(k) number is K951721.

When did APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE receive FDA 510(k) clearance?

APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE received FDA 510(k) clearance on 1995-07-11, under 510(k) number K951721.

Who is the listed applicant for APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE?

The FDA 510(k) record lists Applied Medical Resources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE?

The FDA product code for APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE is LYK.

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Other records listing Applied Medical Resources as applicant

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K200021Applied Medical AnoscopeK162676Voyant Open Fusion DeviceK153017Voyant Fine FusionK153288Voyant Open Fusion DeviceK151480Epix Electrosurgical Probe with Smoke EvacuationK100959SPECIMEN RETRIEVAL SYSTEM

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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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