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FDA 510(k)

A-V SHUNT EXTENSION

K-Number: K771425 · 1978-01-03

ApplicantQuinton, Inc.
Decision Date1978-01-03
Product CodeFKN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

A-V SHUNT EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1978-01-03 under 510(k) number K771425. The device is classified under product code FKN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-V SHUNT EXTENSION?

A-V SHUNT EXTENSION is a medical device that received FDA 510(k) clearance on 1978-01-03. The listed applicant is Quinton, Inc.. The 510(k) number is K771425.

When did A-V SHUNT EXTENSION receive FDA 510(k) clearance?

A-V SHUNT EXTENSION received FDA 510(k) clearance on 1978-01-03, under 510(k) number K771425.

Who is the listed applicant for A-V SHUNT EXTENSION?

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

What is the FDA product code for A-V SHUNT EXTENSION?

The FDA product code for A-V SHUNT EXTENSION is FKN.

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Other records listing Quinton, Inc. as applicant

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Related Devices (Code: FKN)

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.

K893478DA-16 AND DA-24 SHUNT ADAPTERSAkcess Medical Products, Inc.K892667SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313Akcess Medical Products, Inc.K813428SHUNT ADAPTERQuinton, 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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