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FDA 510(k)

SHILEY QUICK DISCONNECT ASSEMBLY

K-Number: K791829 · 1979-10-02

ApplicantShiley, Inc.
Decision Date1979-10-02
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY QUICK DISCONNECT ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1979-10-02 under 510(k) number K791829. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY QUICK DISCONNECT ASSEMBLY?

SHILEY QUICK DISCONNECT ASSEMBLY is a medical device that received FDA 510(k) clearance on 1979-10-02. The listed applicant is Shiley, Inc.. The 510(k) number is K791829.

When did SHILEY QUICK DISCONNECT ASSEMBLY receive FDA 510(k) clearance?

SHILEY QUICK DISCONNECT ASSEMBLY received FDA 510(k) clearance on 1979-10-02, under 510(k) number K791829.

Who is the listed applicant for SHILEY QUICK DISCONNECT ASSEMBLY?

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 SHILEY QUICK DISCONNECT ASSEMBLY?

The FDA product code for SHILEY QUICK DISCONNECT ASSEMBLY is KRI.

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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: KRI)

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.

K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLCK992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia Medical Products, 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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