FDA 510(k)

TS-000 ARTERIOVENOUS BLOOD TUBING SET

K-Number: K822283 · 1982-08-27

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1982-08-27

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TS-000 ARTERIOVENOUS BLOOD TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1982-08-27 under 510(k) number K822283. 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 TS-000 ARTERIOVENOUS BLOOD TUBING SET?

TS-000 ARTERIOVENOUS BLOOD TUBING SET is a medical device that received FDA 510(k) clearance on 1982-08-27. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K822283.

When did TS-000 ARTERIOVENOUS BLOOD TUBING SET receive FDA 510(k) clearance?

TS-000 ARTERIOVENOUS BLOOD TUBING SET received FDA 510(k) clearance on 1982-08-27, under 510(k) number K822283.

Who is the listed applicant for TS-000 ARTERIOVENOUS BLOOD TUBING SET?

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

What is the FDA product code for TS-000 ARTERIOVENOUS BLOOD TUBING SET?

The FDA product code for TS-000 ARTERIOVENOUS BLOOD TUBING SET is KOC.

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Related Devices (Code: KOC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.