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FDA 510(k)

BIONICS ARTERIAL/VENOUS FISTULA NEEDLE

K-Number: K801354 · 1980-07-08

ApplicantCordis Corp.
Decision Date1980-07-08
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIONICS ARTERIAL/VENOUS FISTULA NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801354. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONICS ARTERIAL/VENOUS FISTULA NEEDLE?

BIONICS ARTERIAL/VENOUS FISTULA NEEDLE is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Cordis Corp.. The 510(k) number is K801354.

When did BIONICS ARTERIAL/VENOUS FISTULA NEEDLE receive FDA 510(k) clearance?

BIONICS ARTERIAL/VENOUS FISTULA NEEDLE received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801354.

Who is the listed applicant for BIONICS ARTERIAL/VENOUS FISTULA NEEDLE?

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

What is the FDA product code for BIONICS ARTERIAL/VENOUS FISTULA NEEDLE?

The FDA product code for BIONICS ARTERIAL/VENOUS FISTULA NEEDLE is KOC.

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Related Devices (Code: KOC)

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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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