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FDA 510(k)

SHILEY ELBOW 15MM SWIVEL CONNECTOR

K-Number: K895388 · 1989-10-27

ApplicantShiley, Inc.
Decision Date1989-10-27
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHILEY ELBOW 15MM SWIVEL CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K895388. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY ELBOW 15MM SWIVEL CONNECTOR?

SHILEY ELBOW 15MM SWIVEL CONNECTOR is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Shiley, Inc.. The 510(k) number is K895388.

When did SHILEY ELBOW 15MM SWIVEL CONNECTOR receive FDA 510(k) clearance?

SHILEY ELBOW 15MM SWIVEL CONNECTOR received FDA 510(k) clearance on 1989-10-27, under 510(k) number K895388.

Who is the listed applicant for SHILEY ELBOW 15MM SWIVEL CONNECTOR?

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 ELBOW 15MM SWIVEL CONNECTOR?

The FDA product code for SHILEY ELBOW 15MM SWIVEL CONNECTOR is BZA.

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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: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, 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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