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FDA 510(k)

CARDIOTOMY FILTER

K-Number: K830634 · 1983-06-30

ApplicantTexas Medical Products, Inc.
Decision Date1983-06-30
Product CodeJOD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Products, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K830634. 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 FILTER?

CARDIOTOMY FILTER is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K830634.

When did CARDIOTOMY FILTER receive FDA 510(k) clearance?

CARDIOTOMY FILTER received FDA 510(k) clearance on 1983-06-30, under 510(k) number K830634.

Who is the listed applicant for CARDIOTOMY FILTER?

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

What is the FDA product code for CARDIOTOMY FILTER?

The FDA product code for CARDIOTOMY FILTER is JOD.

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Other records listing Texas Medical Products, 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.

K893417SURGIFRESH SUB-MICRON MASK NO. 901008-000K870932SURGIFRESH SURGICAL SMOKE REMOVALK851575DR. BRUNO LNAGE MINI PHOTOMETERK813587DISPOSABLE THORACIC CATHETERK810532DISPOSABLE STOPCOCKK810515DISPOSABLE 2-STAGE CANNULA

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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.K890504CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUSGish Biomedical, 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.

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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