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FDA 510(k)

RMI CARDIOPLEGIA DELIVERY SETS

K-Number: K892368 · 1989-12-07

ApplicantResearch Medical, Inc.
Decision Date1989-12-07
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RMI CARDIOPLEGIA DELIVERY SETS 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 1989-12-07 under 510(k) number K892368. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMI CARDIOPLEGIA DELIVERY SETS?

RMI CARDIOPLEGIA DELIVERY SETS is a medical device that received FDA 510(k) clearance on 1989-12-07. The listed applicant is Research Medical, Inc.. The 510(k) number is K892368.

When did RMI CARDIOPLEGIA DELIVERY SETS receive FDA 510(k) clearance?

RMI CARDIOPLEGIA DELIVERY SETS received FDA 510(k) clearance on 1989-12-07, under 510(k) number K892368.

Who is the listed applicant for RMI CARDIOPLEGIA DELIVERY SETS?

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 CARDIOPLEGIA DELIVERY SETS?

The FDA product code for RMI CARDIOPLEGIA DELIVERY SETS is DTL.

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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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