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FDA 510(k)

IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)

K-Number: K871596 · 1987-06-15

ApplicantShiley, Inc.
Decision Date1987-06-15
Product CodeDTJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1987-06-15 under 510(k) number K871596. 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 PERICARDIAL XENOGRAFT (ISU)?

IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) is a medical device that received FDA 510(k) clearance on 1987-06-15. The listed applicant is Shiley, Inc.. The 510(k) number is K871596.

When did IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) receive FDA 510(k) clearance?

IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) received FDA 510(k) clearance on 1987-06-15, under 510(k) number K871596.

Who is the listed applicant for IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)?

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 PERICARDIAL XENOGRAFT (ISU)?

The FDA product code for IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) 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 CorpK864155MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESISAmerican Edwards Laboratories

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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