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FDA 510(k)

QUICKIE PRIME CARDIOP. BYPASS PERF. INTR

K-Number: K801402 · 1980-06-30

ApplicantTexas Medical Products, Inc.
Decision Date1980-06-30
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUICKIE PRIME CARDIOP. BYPASS PERF. INTR 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 1980-06-30 under 510(k) number K801402. 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 QUICKIE PRIME CARDIOP. BYPASS PERF. INTR?

QUICKIE PRIME CARDIOP. BYPASS PERF. INTR is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K801402.

When did QUICKIE PRIME CARDIOP. BYPASS PERF. INTR receive FDA 510(k) clearance?

QUICKIE PRIME CARDIOP. BYPASS PERF. INTR received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801402.

Who is the listed applicant for QUICKIE PRIME CARDIOP. BYPASS PERF. INTR?

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 QUICKIE PRIME CARDIOP. BYPASS PERF. INTR?

The FDA product code for QUICKIE PRIME CARDIOP. BYPASS PERF. INTR 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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