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FDA 510(k)

IONESCU-SHILEY VALVE HOLDER & HANDLE

K-Number: K813276 · 1981-12-10

ApplicantShiley, Inc.
Decision Date1981-12-10
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IONESCU-SHILEY VALVE HOLDER & HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1981-12-10 under 510(k) number K813276. The device is classified under product code DTJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONESCU-SHILEY VALVE HOLDER & HANDLE?

IONESCU-SHILEY VALVE HOLDER & HANDLE is a medical device that received FDA 510(k) clearance on 1981-12-10. The listed applicant is Shiley, Inc.. The 510(k) number is K813276.

When did IONESCU-SHILEY VALVE HOLDER & HANDLE receive FDA 510(k) clearance?

IONESCU-SHILEY VALVE HOLDER & HANDLE received FDA 510(k) clearance on 1981-12-10, under 510(k) number K813276.

Who is the listed applicant for IONESCU-SHILEY VALVE HOLDER & HANDLE?

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 IONESCU-SHILEY VALVE HOLDER & HANDLE?

The FDA product code for IONESCU-SHILEY VALVE HOLDER & HANDLE is DTJ.

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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: DTJ)

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.

K962154CARBOMEDICS HANDLECarbomedics, Inc.K960169CARBOMEDICS VALVE TESTERCarbomedics, Inc.K944214BAXTER HANDLE MODEL 1150Baxter EdwardsK942736CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLECarbomedics, Inc.K880052EDWARDS-DUROMEDICS MITRAL VALVE ROTATORBaxter Healthcare CorpK871596IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)Shiley, 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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