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FDA 510(k)

CARDIOPLEGIC SETS

K-Number: K802545 · 1981-01-16

ApplicantTexas Medical Products, Inc.
Decision Date1981-01-16
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIC SETS is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Products, Inc.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K802545. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOPLEGIC SETS?

CARDIOPLEGIC SETS is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K802545.

When did CARDIOPLEGIC SETS receive FDA 510(k) clearance?

CARDIOPLEGIC SETS received FDA 510(k) clearance on 1981-01-16, under 510(k) number K802545.

Who is the listed applicant for CARDIOPLEGIC SETS?

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

What is the FDA product code for CARDIOPLEGIC SETS?

The FDA product code for CARDIOPLEGIC SETS is DTR.

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Related Devices (Code: DTR)

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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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