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FDA 510(k)

CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700

K-Number: K884640 · 1989-01-24

ApplicantAmerican Omni Medical, Inc.
Decision Date1989-01-24
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 is the device name listed in this FDA 510(k) record. The listed applicant is American Omni Medical, Inc.. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K884640. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700?

CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K884640.

When did CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 receive FDA 510(k) clearance?

CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 received FDA 510(k) clearance on 1989-01-24, under 510(k) number K884640.

Who is the listed applicant for CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700?

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

What is the FDA product code for CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700?

The FDA product code for CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 is KRI.

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Other records listing American Omni Medical, Inc. as applicant

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Related Devices (Code: KRI)

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.

K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLCK992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia 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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