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FDA 510(k)

RMI EXTERNAL CORONARY ARTERY OCCLUDER

K-Number: K920936 · 1992-12-18

ApplicantResearch Medical, Inc.
Decision Date1992-12-18
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RMI EXTERNAL CORONARY ARTERY OCCLUDER is the device name listed in this FDA 510(k) record. The listed applicant is Research Medical, Inc.. It received FDA 510(k) clearance on 1992-12-18 under 510(k) number K920936. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMI EXTERNAL CORONARY ARTERY OCCLUDER?

RMI EXTERNAL CORONARY ARTERY OCCLUDER is a medical device that received FDA 510(k) clearance on 1992-12-18. The listed applicant is Research Medical, Inc.. The 510(k) number is K920936.

When did RMI EXTERNAL CORONARY ARTERY OCCLUDER receive FDA 510(k) clearance?

RMI EXTERNAL CORONARY ARTERY OCCLUDER received FDA 510(k) clearance on 1992-12-18, under 510(k) number K920936.

Who is the listed applicant for RMI EXTERNAL CORONARY ARTERY OCCLUDER?

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

What is the FDA product code for RMI EXTERNAL CORONARY ARTERY OCCLUDER?

The FDA product code for RMI EXTERNAL CORONARY ARTERY OCCLUDER is DXC.

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Other records listing Research Medical, Inc. as applicant

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Related Devices (Code: DXC)

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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