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FDA 510(k)

CARDIO METRICS INVASIVE PRESSURE MONIT

K-Number: K841960 · 1985-11-08

ApplicantSterile Design, Inc.
Decision Date1985-11-08
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO METRICS INVASIVE PRESSURE MONIT 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 1985-11-08 under 510(k) number K841960. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO METRICS INVASIVE PRESSURE MONIT?

CARDIO METRICS INVASIVE PRESSURE MONIT is a medical device that received FDA 510(k) clearance on 1985-11-08. The listed applicant is Sterile Design, Inc.. The 510(k) number is K841960.

When did CARDIO METRICS INVASIVE PRESSURE MONIT receive FDA 510(k) clearance?

CARDIO METRICS INVASIVE PRESSURE MONIT received FDA 510(k) clearance on 1985-11-08, under 510(k) number K841960.

Who is the listed applicant for CARDIO METRICS INVASIVE PRESSURE MONIT?

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 INVASIVE PRESSURE MONIT?

The FDA product code for CARDIO METRICS INVASIVE PRESSURE MONIT is DRS.

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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 DESIGNK842356CUSTOM STERILE PROCEDURE KITSK841959CARDIO METRIC CUSTOM PERFUSION TUBINGK842351STERILE DESIGN-CUSTOM STERILE IV KITK841958CARDIO METRICS CARDIOTOMY RESERVOIRK834239SDI C-FLEX STERILE LIGHT HANDLE

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Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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