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FDA 510(k)

DIAGNOSTIC INTRAVASCULAR CATHETER

K-Number: K930758 · 1993-09-24

ApplicantApplied Medical Resources
Decision Date1993-09-24
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC INTRAVASCULAR CATHETER 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 1993-09-24 under 510(k) number K930758. 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 DIAGNOSTIC INTRAVASCULAR CATHETER?

DIAGNOSTIC INTRAVASCULAR CATHETER is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Applied Medical Resources. The 510(k) number is K930758.

When did DIAGNOSTIC INTRAVASCULAR CATHETER receive FDA 510(k) clearance?

DIAGNOSTIC INTRAVASCULAR CATHETER received FDA 510(k) clearance on 1993-09-24, under 510(k) number K930758.

Who is the listed applicant for DIAGNOSTIC INTRAVASCULAR CATHETER?

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 DIAGNOSTIC INTRAVASCULAR CATHETER?

The FDA product code for DIAGNOSTIC INTRAVASCULAR CATHETER is LYK.

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Other records listing Applied Medical Resources as applicant

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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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