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FDA 510(k)

ANGIOLAZ ANGIOSCOPE CATHETER

K-Number: K913129 · 1991-12-27

ApplicantAngiolaz, Inc.
Decision Date1991-12-27
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANGIOLAZ ANGIOSCOPE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Angiolaz, Inc.. It received FDA 510(k) clearance on 1991-12-27 under 510(k) number K913129. 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 ANGIOLAZ ANGIOSCOPE CATHETER?

ANGIOLAZ ANGIOSCOPE CATHETER is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is Angiolaz, Inc.. The 510(k) number is K913129.

When did ANGIOLAZ ANGIOSCOPE CATHETER receive FDA 510(k) clearance?

ANGIOLAZ ANGIOSCOPE CATHETER received FDA 510(k) clearance on 1991-12-27, under 510(k) number K913129.

Who is the listed applicant for ANGIOLAZ ANGIOSCOPE CATHETER?

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

What is the FDA product code for ANGIOLAZ ANGIOSCOPE CATHETER?

The FDA product code for ANGIOLAZ ANGIOSCOPE CATHETER is LYK.

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Other records listing Angiolaz, 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.

K994362HEADLAMP HL2000.K99244750 W METAL HALIDE ILLUMINATOR, VES 0501.K982397VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEMK982409VES 1501-MK981819ANGIOLAZ VES-1CAMK981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR

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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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