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FDA 510(k)

PERFUSION TUBING SET

K-Number: K760922 · 1976-11-19

ApplicantShiley, Inc.
Decision Date1976-11-19
Product CodeKDL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERFUSION TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1976-11-19 under 510(k) number K760922. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFUSION TUBING SET?

PERFUSION TUBING SET is a medical device that received FDA 510(k) clearance on 1976-11-19. The listed applicant is Shiley, Inc.. The 510(k) number is K760922.

When did PERFUSION TUBING SET receive FDA 510(k) clearance?

PERFUSION TUBING SET received FDA 510(k) clearance on 1976-11-19, under 510(k) number K760922.

Who is the listed applicant for PERFUSION TUBING SET?

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

What is the FDA product code for PERFUSION TUBING SET?

The FDA product code for PERFUSION TUBING SET is KDL.

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Other records listing Shiley, 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.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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Related Devices (Code: KDL)

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.

K241239OrganProtex HTK SolutionBridge TO Life, Ltd.K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges LopezK221387BEL-GEN Cold Storage SolutionInstitut Georges LopezK211842Servator M SALF SolutionS.A.L.F. SpaK192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbHK170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa

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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