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FDA 510(k)

CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25

K-Number: K884893 · 1989-01-30

ApplicantAmerican Omni Medical, Inc.
Decision Date1989-01-30
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 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 1989-01-30 under 510(k) number K884893. 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 CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25?

CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K884893.

When did CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 receive FDA 510(k) clearance?

CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884893.

Who is the listed applicant for CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25?

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 CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25?

The FDA product code for CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 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.

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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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