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FDA 510(k)

CARDIO METRICS CARDIOTOMY RESERVOIR

K-Number: K841958 · 1984-10-15

ApplicantSterile Design, Inc.
Decision Date1984-10-15
Product CodeJOD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO METRICS CARDIOTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Design, Inc.. It received FDA 510(k) clearance on 1984-10-15 under 510(k) number K841958. 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 CARDIO METRICS CARDIOTOMY RESERVOIR?

CARDIO METRICS CARDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 1984-10-15. The listed applicant is Sterile Design, Inc.. The 510(k) number is K841958.

When did CARDIO METRICS CARDIOTOMY RESERVOIR receive FDA 510(k) clearance?

CARDIO METRICS CARDIOTOMY RESERVOIR received FDA 510(k) clearance on 1984-10-15, under 510(k) number K841958.

Who is the listed applicant for CARDIO METRICS CARDIOTOMY RESERVOIR?

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

What is the FDA product code for CARDIO METRICS CARDIOTOMY RESERVOIR?

The FDA product code for CARDIO METRICS CARDIOTOMY RESERVOIR is JOD.

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Other records listing Sterile Design, 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.

K934688STERILE DESIGNK841960CARDIO METRICS INVASIVE PRESSURE MONITK842356CUSTOM STERILE PROCEDURE KITSK841959CARDIO METRIC CUSTOM PERFUSION TUBINGK842351STERILE DESIGN-CUSTOM STERILE IV KITK834239SDI C-FLEX STERILE LIGHT HANDLE

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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.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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