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FDA 510(k)

CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS

K-Number: K890504 · 1989-03-10

ApplicantGish Biomedical, Inc.
Decision Date1989-03-10
Product CodeJOD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1989-03-10 under 510(k) number K890504. The device is classified under product code JOD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS?

CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS is a medical device that received FDA 510(k) clearance on 1989-03-10. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K890504.

When did CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS receive FDA 510(k) clearance?

CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS received FDA 510(k) clearance on 1989-03-10, under 510(k) number K890504.

Who is the listed applicant for CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS?

The FDA 510(k) record lists Gish Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS?

The FDA product code for CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS is JOD.

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Other records listing Gish Biomedical, Inc. as applicant

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Related Devices (Code: JOD)

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.

K993060GAS FILTEROlson Medical Sales, Inc.K875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANEPall Biomedical Products Co.K874405PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USEPall Biomedical Products Co.K855067SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100Cobe Laboratories, Inc.K841958CARDIO METRICS CARDIOTOMY RESERVOIRSterile Design, Inc.K830634CARDIOTOMY FILTERTexas 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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