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FDA 510(k)

ANGIOSCOPE

K-Number: K830084 · 1983-06-02

ApplicantTrimedyne, Inc.
Decision Date1983-06-02
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANGIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K830084. 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 ANGIOSCOPE?

ANGIOSCOPE is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Trimedyne, Inc.. The 510(k) number is K830084.

When did ANGIOSCOPE receive FDA 510(k) clearance?

ANGIOSCOPE received FDA 510(k) clearance on 1983-06-02, under 510(k) number K830084.

Who is the listed applicant for ANGIOSCOPE?

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

What is the FDA product code for ANGIOSCOPE?

The FDA product code for ANGIOSCOPE is LYK.

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Other records listing Trimedyne, 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.

K053457VAPORMAX IIK050412VAPORMAXK043012OMNIPULSE MINI, MODEL 2120K041660TRIMEDYNE HOLMIUM LASER SYSTEMSK022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHK013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A

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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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