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FDA 510(k)

DIDECO-SHILEY UNIVERSAL Y

K-Number: K894294 · 1989-08-15

ApplicantShiley, Inc.
Decision Date1989-08-15
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DIDECO-SHILEY UNIVERSAL Y is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K894294. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIDECO-SHILEY UNIVERSAL Y?

DIDECO-SHILEY UNIVERSAL Y is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Shiley, Inc.. The 510(k) number is K894294.

When did DIDECO-SHILEY UNIVERSAL Y receive FDA 510(k) clearance?

DIDECO-SHILEY UNIVERSAL Y received FDA 510(k) clearance on 1989-08-15, under 510(k) number K894294.

Who is the listed applicant for DIDECO-SHILEY UNIVERSAL Y?

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 DIDECO-SHILEY UNIVERSAL Y?

The FDA product code for DIDECO-SHILEY UNIVERSAL Y is CAC.

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Other records listing Shiley, Inc. as applicant

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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: CAC)

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.

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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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