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FDA 510(k)

DISPOSABLE STEERABLE ANGIOSCOPE

K-Number: K931421 · 1993-06-16

ApplicantEndovascular, Inc.
Decision Date1993-06-16
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE STEERABLE ANGIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Endovascular, Inc.. It received FDA 510(k) clearance on 1993-06-16 under 510(k) number K931421. 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 DISPOSABLE STEERABLE ANGIOSCOPE?

DISPOSABLE STEERABLE ANGIOSCOPE is a medical device that received FDA 510(k) clearance on 1993-06-16. The listed applicant is Endovascular, Inc.. The 510(k) number is K931421.

When did DISPOSABLE STEERABLE ANGIOSCOPE receive FDA 510(k) clearance?

DISPOSABLE STEERABLE ANGIOSCOPE received FDA 510(k) clearance on 1993-06-16, under 510(k) number K931421.

Who is the listed applicant for DISPOSABLE STEERABLE ANGIOSCOPE?

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

What is the FDA product code for DISPOSABLE STEERABLE ANGIOSCOPE?

The FDA product code for DISPOSABLE STEERABLE ANGIOSCOPE 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 Endovascular, 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.

K924075DISPOSABLE OPTICAL VALVULOTOMEK923996DISPOSABLE VASCULAR ANGIOSCOPE

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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